Naptumomab Estafenatox in Combination With Durvalumab in Subjects With Selected Advanced or Metastatic Solid Tumors

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Brief Title

Naptumomab Estafenatox in Combination With Durvalumab in Subjects With Selected Advanced or Metastatic Solid Tumors

Official Title

Phase 1B, Open-Label, Dose Escalation and Cohort Expansions Trial of Naptumomab Estafenatox (NAP, ABR-217620) in Combination With Durvalumab (MEDI4736) in Subjects With Selected Advanced or Metastatic Solid Tumors

Brief Summary

      This is a dose escalation, MTD expansion (Phase 1b) and cohort expansions (Phase 2) study to
      assess the safety and tolerability of a combination of NAP with durvalumab in subjects with
      selected advanced or metastatic solid tumors.
    

Detailed Description

      This Phase 1b, open-label, multicenter (n=3-5), prospective, dose-finding and MTD cohort
      expansion study, will accrue patients with previously treated solid tumors known with high
      likelihood of 5T4 antigen expression on tumor cells.

      Patients in the dose-escalation part will be treated with the combination of NAP and
      durvalumab using a fixed dose of durvalumab and the 3+3 design for NAP dose escalations. The
      (Maximum Tolerated Dose (MTD) of NAP for the combination treatment will be established based
      on Dose Limiting Toxicities (DLTs) occurring during the first cycle of the treatment.

      A second dose escalation part is performed at the second highest safe dose in the dose
      escalation phase, pre-treated with obinutuzumab (anti-CD20), for elimination of anti-drug
      antibodies (ADAs) to NAP. In this part, the safety of the NAP-durvalumab combination will be
      assessed with obinutuzumab given prior to the initiation of that regimen. If safety and
      successful elimination of ADAs is confirmed, pretreatment with obinutuzumab will be tested
      further in the MTD expansion cohort.

      MTD expansion part, in which 10-15 patients will be treated at the confirmed MTD of NAP. This
      cohort will accrue patients with the same tumor types as in the escalation part, as well as
      5T4-positive colorectal cancer (CRC) and gastro-esophageal cancer (GE). Measurable disease,
      available tumor deposit and repeat biopsy are required. This expansion cohort will help
      assess the biologic activity of the combination and to gain some preliminary insights on its
      potential antitumor activity.

      The following solid tumors known to have > 80% probability of 5T4 expression and thus may be
      included in both the dose escalation phase and the MTD expansion: breast cancer, epithelial
      ovarian cancer, cervical and endometrial cancer, pancreatic cancer, renal and urothelial
      cancer, head and neck, mesothelioma, melanoma, hepatic carcinoma, prostate cancer, and
      Non-Small Cell Lung Cancer (NSCLC). Prior PD-1 or PD-L1 therapy is acceptable.
    

Study Phase

Phase 1

Study Type

Interventional


Primary Outcome

The incidence and characteristics of adverse events, associated with ascending doses of NAP in combination with a set dose of durvalumab

Secondary Outcome

 Disease parameters: ORR, DOR, PFS, OS

Condition

ER+ Breast Cancer

Intervention

Obinutuzumab pretreatment (Gazyva®) Naptumomab estafenatox (ABR-217620; NAP) and durvalumab (IMFINZI; MEDI4736)

Study Arms / Comparison Groups

 Naptumomab estafenatox 2 µg/kg and durvalumab
Description:  NAP is to be administered on the first four days of each 21-day cycle, at daily doses of 2 µg/kg. Durvalumab (1120 mg, IV, 1- 1.5 hours after completion of the administration of NAP) will be administered on the second day of each 21-day cycle. After cycle 3, patients will continue to receive durvalumab alone at a dose of 1500 mg delivered once every 28 days, until confirmed disease progression or unacceptable toxicity for a maximum of up to 24 months.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Combination Product

Estimated Enrollment

45

Start Date

October 10, 2019

Completion Date

February 28, 2022

Primary Completion Date

November 1, 2021

Eligibility Criteria

        Inclusion Criteria:

          1. Adult at least 18 years of age

          2. Histologically and/or cytologically confirmed solid tumor from the following list,
             that is metastatic/advanced, for which no curative therapy exists:

               1. pancreatic adenocarcinoma

               2. high-grade serous ovarian cancer

               3. cervical squamous cell carcinoma

               4. prostate cancer

               5. ER+/HER2- or triple-negative breast cancer

               6. NSCLC including driver mutation-positive.

               7. mesothelioma

               8. renal cell carcinoma

               9. bladder/urothelial cancer

              10. head and neck squamous cell carcinoma

              11. melanoma

              12. hepatocellular carcinoma

              13. endometrial cancer

              14. MTD expansion cohort only: 5T4-positive colorectal cancer and 5T4-positive
                  gastroesophageal cancer

          3. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1

          4. a. All patients must provide signed informed consent prior to any study specific
             procedures that are not part of standard medical care.

             b. Patients in the MTD expansion cohort must also provide their consent to undergo 2
             tumor biopsies: one prior to treatment (during screening) and the second on cycle 1
             day 4. An archival biopsy will be acceptable as baseline biopsy if it was collected
             within the 3 months preceding screening. Otherwise, a fresh biopsy is required.
             Patients enrolled in the MTD expansion cohort after prior exposure to a checkpoint
             inhibitor should have a baseline biopsy obtained after completion of the last prior
             checkpoint inhibitor therapy.

          5. Presence of clinically and/or radiologically documented disease. All radiology studies
             must be performed within 28 days prior to subject enrolment (subject enrolment=Day 1)

             a. Dose escalation part: patients do not need to have measurable disease by RECIST 1.1
             b. MTD dose expansion part: patients must have measurable disease by RECIST 1.1 and at
             least one additional accessible lesion for biopsy. Previously irradiated lesions may
             be considered measurable if there has been demonstrated progression in these lesions.

          6. Previous therapy:

             i. All patients must have received at least 1 standard systemic cancer therapy for
             their tumor type and progressed following their most recent regimen. There is no limit
             to the number of prior cytotoxic regimens received.

             ii. Treatment-naïve patients will be eligible only if they refused standard treatment.

             iii. Patients with prior anti-PD-1, anti PD-L1 or anti CTLA4 therapy are eligible if
             they have received such therapy for a minimum of 6 months and if they have documented
             progression of their disease on or off such therapy.

          7. Previously treated brain metastases must be asymptomatic without MRI evidence of
             progression for at least 8 weeks and off steroids for at least 4 weeks before study
             drug administration to be eligible.

          8. At least 21 days since the last chemotherapy, immunotherapy, biological (except for
             erythropoietin, denosumab and bisphosphonates), and at least 2 weeks from approved
             tyrosine kinase or mTOR inhibitors therapy and recovery to grade 1 or less (except for
             alopecia) from any toxicity associated with such treatment.

          9. Systemic prednisone therapy ≤10 mg/day or equivalent is acceptable. Higher doses are
             not acceptable within 1 week prior to start of study treatment and as long as patient
             is treated with Nap, unless administered to treated Nap-related adverse events. There
             is no limit on topical, intranasal or inhaled corticosteroids.

         10. Prior major surgery completed at least 4 weeks before study drug administration.

         11. Adequate hematologic and organ function: WBC ≥3000/μL; neutrophils ≥1500/μL; platelets
             ≥100,000/μL; hemoglobin ≥9.0 g/dL (may have been transfused); creatinine ≤ 1.5 mg/dL;
             measured creatinine clearance >40 mL/min or calculated creatinine clearance (CL) > 40,
             as determined by Cockcroft-Gault (using actual body weight); AST ≤2.5 X ULN; ALT ≤2.5
             X ULN (for patients with known liver involvement: AST and ALT ≤5 x ULN).; bilirubin ≤
             1.5 mg/dL (unless diagnosed with Gilbert's syndrome); Coagulation International
             Normalized Ratio (INR) or Prothrombin Time (PT) and Activated Partial Thromboplastin
             Time (aPTT) ≤1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT
             or PTT is within therapeutic range of intended use of anticoagulants.

         12. Patients must be willing and able to comply with scheduled visits, drug administration
             plan, hospitalization for treatment (if needed) and scheduled follow-up visits and
             examinations as outlined in the protocol, including procedures undertaken to perform
             fresh tumor biopsies as per protocol

         13. Must have a life expectancy of at least 12 weeks

        Exclusion criteria:

          1. Body weight <30kg

          2. Patients with a history of other malignancies requiring concurrent anticancer therapy.

          3. Active or prior documented autoimmune or inflammatory disorders (including
             inflammatory bowel disease [e.g. colitis or Crohn's disease], or other serious
             gastrointestinal chronic conditions associated with diarrhea), systemic lupus
             erythematosus, or Wegener syndrome (granulomatosis with polyangiitis), rheumatoid
             arthritis, uveitis, etc., within the past 2 years prior to the start of treatment. The
             following are exceptions to this criterion:

               1. Patients with Graves' disease, vitiligo or psoriasis not requiring systemic
                  treatment (within the last 2 years).

               2. Patients with endocrinopathies (e.g. following Hashimoto syndrome) stable on
                  hormone replacement or do not require any therapy.

          4. History of primary immunodeficiency, history of allogenic organ transplant that
             requires therapeutic immunosuppression and the use of immunosuppressive agents within
             28 days of enrollment.

             NOTE: Intranasal/inhaled corticosteroids or systemic steroids that do not exceed 10
             mg/day of prednisone or equivalent dose of an alternative corticosteroid are
             permissible

          5. Patients who have uncontrolled inter-current illness, including but not limited to,
             ongoing or active infection, symptomatic congestive heart failure, uncontrolled
             hypertension, unstable angina pectoris, uncontrolled cardiac arrhythmia, active
             interstitial lung disease, serious chronic gastrointestinal conditions associated with
             diarrhea, or psychiatric illness/social situations that would limit compliance with
             study requirement, substantially increase risk of incurring AEs or compromise the
             ability of the patient to give written informed consent.

          6. Recent history of live attenuated vaccine within 30 days prior to the first dose of
             study drug.

             NOTE: Patients, once enrolled, should not receive live vaccine whilst receiving study
             drug and up to 30 days after the last dose of study drug.

          7. Known current drug or alcohol abuse

          8. Known active or latent tuberculosis (TB) infection (purified protein derivative [PPD]
             test is not required) as indicated by any of the following: PPD recently converted to
             positive; chest x-ray with evidence of infections infiltrate.

          9. Hepatitis B (known positive HBV surface antigen (HBsAg) result), hepatitis C. Patients
             with a past or resolved HBV infection (defined as the presence of hepatitis B core
             antibody [anti-HBc] and absence of HBsAg) are eligible. Patients positive for
             hepatitis C (HCV) antibody are eligible only if polymerase chain reaction (PCR) is
             negative for HCV RNA.

         10. Evidence for human immunodeficiency virus (HIV) (positive HIV 1/2 antibodies)

         11. Underlying medical conditions that, in the Principal Investigator's opinion, will make
             the administration of study drug hazardous or obscure the interpretation of toxicity
             determination or adverse events

         12. Female patients who are pregnant or breastfeeding or male or female patients of
             reproductive potential who are not willing to employ effective birth control from
             screening to 90 days after the last dose of study treatment (either durvalumab
             monotherapy or durvalumab + Nap combination therapy).

             * Highly effective methods of contraception are defined as one that results in a low
             failure rate (e.g., less than 1% per year) when used consistently and correctly. Note
             that some contraception methods are not considered highly effective (e.g., male or
             female condom with or without spermicide; female cap, diaphragm, or sponge with or
             without spermicide; non-copper containing intrauterine device; progestogen-only oral
             hormonal contraceptive pills where inhibition of ovulation is not the primary mode of
             action [excluding Cerazette/desogestrel which is considered highly effective]; and
             triphasic combined oral contraceptive pills).

         13. Simultaneous participation in any other study involving investigational drugs or
             having participated in study less than 4 weeks prior to start of study treatment

         14. History of leptomeningeal carcinomatosis

         15. History of active primary immunodeficiency

         16. Any unresolved toxicity NCI CTCAE Grade ≥2 from previous anticancer therapy with the
             exception of alopecia, vitiligo, and the laboratory values defined in the inclusion
             criteria

         17. Patients with Grade ≥2 neuropathy will be evaluated on a case-by-case basis after
             consultation with the Sponsor.

         18. Patients with irreversible toxicity not reasonably expected to be exacerbated by
             treatment with Nap or durvalumab (or Obi, in the cohorts receiving Obi pretreatment)
             may be included only after consultation with the Sponsor.

         19. Mean QT interval corrected for heart rate using Fridericia's formula (QTcF) ≥450 ms in
             male patients, and ≥470 ms in female patients. If the first ECG result is normal, no
             triplicate test is required. However, any clinically significant abnormalities
             detected on the 1st ECG will require triplicate ECG result, calculated from 3 ECGs
             (within 15 minutes at 5 minutes apart)

         20. Known allergy or hypersensitivity to any of the study drugs or any of the study drug
             excipients

         21. Known hypersensitivity to other recombinant human antibodies

         22. Major surgical procedure (as defined by the Investigator) within 28 days prior to the
             first dose of IP. Local surgery of isolated lesions for palliative intent is
             acceptable.

         23. Patients who have received prior anti-PD-1, anti PD-L1 or anti CTLA-4:

               -  Must not have experienced a toxicity that led to permanent discontinuation of
                  prior immunotherapy.

               -  All AEs while receiving prior immunotherapy must have completely resolved or
                  resolved to < Grade 1 prior to screening for this study.

               -  Must not have experienced a Grade ≥3 immune-related AE or an immune-related
                  neurologic or ocular AE of any grade while receiving prior immunotherapy.
                  Patients with an endocrine AE of Grade ≤2 are permitted to enroll if they are
                  stably maintained on appropriate replacement therapy and are asymptomatic.

               -  Must not have required the use of additional immunosuppression other than
                  corticosteroids for the management of an AE, not have experienced recurrence of
                  an immune related AE of any grade if re-challenged, and not currently require
                  maintenance doses of >10 mg prednisone or equivalent per day.

         24. Involvement in planning and/or conduct of the study (applies to both sponsor staff
             and/or staff at the study site).

         25. History of progressive multifocal leukoencephalopathy (PML)
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Ilana Lorber, MD, 97239125853, [email protected]

Location Countries

Israel

Location Countries

Israel

Administrative Informations


NCT ID

NCT03983954

Organization ID

127-CL-01


Responsible Party

Sponsor

Study Sponsor

NeoTX Therapeutics Ltd.

Collaborators

 AstraZeneca

Study Sponsor

Ilana Lorber, MD, Study Director, NeoTX Therapeutics Ltd.


Verification Date

October 2020