A Phase 1 Study of ZSP1241 in Participants With Advanced Solid Tumors

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Brief Title

A Phase 1 Study of ZSP1241 in Participants With Advanced Solid Tumors

Official Title

A Phase 1, Open-Label, Dose-Escalation and Expansion, Safety and Tolerability Study of ZSP1241 in Participants With Advanced Solid Tumors

Brief Summary

      The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics, and
      determine the maximum tolerated dose of ZSP1241 in participants with hepatocellular
      carcinoma, cholangiocarcinoma, gastric cancer, esophageal cancer, colorectal cancer and other
      advanced solid tumors.
    


Study Phase

Phase 1

Study Type

Interventional


Primary Outcome

Safety and tolerability of ZSP1241 in single dose ascending (SAD) and multiple dose ascending (MAD) as measured by assessment of maximum tolerated dose (MTD), dose limiting toxicity (DLT) and treatment emergent adverse events (TEAEs)

Secondary Outcome

 Time to progression (TTP).

Condition

Hepatocellular Carcinoma

Intervention

ZSP1241

Study Arms / Comparison Groups

 Part 1
Description:  Participants with advanced solid tumors including hepatocellular carcinoma, cholangiocarcinoma, gastric cancer, esophageal cancer, colorectal cancer and other advanced solid tumors.

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

Drug

Estimated Enrollment

90

Start Date

November 13, 2018

Completion Date

October 31, 2021

Primary Completion Date

October 31, 2021

Eligibility Criteria

        Inclusion Criteria:

          -  Participants are required to meet all the criteria below in order to be included in
             the trial:

               1. Male or female patient, aged 18 ~ 75 years.

               2. Confirmed diagnosis of advanced solid tumors by histological or cytological
                  examination, participants have no effective standard anticancer therapy available
                  or is intolerant to standard anticancer therapy.

               3. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.

               4. Participants with at least 1 measurable tumor lesion based on RECIST 1.1.

               5. Recovery from past medical history of adverse reactions (excluding alopecia and
                  neurotoxicity) caused by radiotherapy and/or chemotherapy to NCI CTCAE 5.0 Grade
                  ≤ 1 or baseline level.

               6. Life expectancy ≥ 12 weeks.

               7. Adequate organ function, defined by the following laboratory results, to be
                  obtained prior to enrollment:

                  Bone marrow function: ANC≥1.5×109/L; HB≥90 g/L; PLT≥75×109/L. Liver function:
                  ALT≤2.5×ULN, AST≤2.5×ULN, ALP≤2.5×ULN, TBIL≤1.5×ULN; ALT≤5×ULN, AST≤5×ULN (For
                  participants with liver focal masses and metastasis).

                  Renal function: creatinine≤1.5×ULN; CL≥ 50 mL/min. Coagulation function:
                  INR≤1.5×ULN; INR≤2.3×ULN (For participants with liver focal masses and
                  metastasis).

               8. Child-Pugh class A (only for hepatocellular carcinoma and cholangiocarcinoma).

               9. Participants (including partners) who have no gestation plans and are willing to
                  follow reliable contraceptive measures during the study and until 8 months after
                  the last dosing.

              10. Participants with voluntarily signature Informed Consent Form (ICF) prior to
                  screening.

        Exclusion Criteria:

          -  Eligible participants must not meet any of the following exclusion criteria:

               1. Participants who have intracranial tumor and/or brain metastases with clinical
                  symptoms needed treatment are ineligible not including the following :

                    1. recovery from the therapy (including radiotherapy and/or surgery) 4 weeks
                       before enrollment.

                    2. participants with intracranial tumor who are clinically stable during
                       screening and enrollment, no need to medication by hormone or
                       anticonvulsants, and predicted to be clinically stable during the study.

               2. Participants who suffer from chronic and active infective diseases and require
                  systemic antibiotic, antifungal, or antiviral treatment except concomitant
                  antiviral systemic therapy for chronic hepatitis B or C.

               3. Participants with dysphagia.

               4. Participants with incontrollable hydrops in third lumen such as malignant pleural
                  effusion and ascites.

               5. Participants with history of pulmonary fibrosis or interstitial pneumonia
                  including pneumoconiosis and radiation pulmonary fibrosis beyond radiation field.

               6. Participants who suffer from irritable bowel syndrome and need medication.

               7. Participants with any clinically significant gastrointestinal abnormalities such
                  as Crohn's disease, ulcerative colitis and subtotal gastrectomy.

               8. Participants with major surgery in recent 4 weeks or active peptic ulcer disease
                  or unrecovered wound.

               9. Participants with history of myocardial infarction or congestive heart-failure
                  (CHF) at NYHA≥3 level within 6 months prior to enrollment.

              10. Participants with LVEF<50% during screening.

              11. Participants with QTcF prolongations in ECG baseline ( QTcF>450ms for males or
                  QTcF>470ms for females) or high risk factors leading to QT intervals prolonging
                  (including hypokalemia, familial QT interval prolongation syndrome) or a history
                  of uncontrollable blood pressure or a history of severe or uncontrollable
                  ventricular arrhythmia such as two or three degree atrioventricular block.

              12. Participants with medications known as QTc prolongation or TDP ventricular
                  tachycardia inducer or strong inhibitors and inducers of CYP3A4 not less than 5
                  days or 5 half-times before first dosing ZSP1241.

              13. Participants with history of most recently chemotherapy, radiotherapy, or
                  non-antibody antitumor biologics within 4 weeks prior to the first ZSP1241
                  treatment and last time medication of nitrosoureas, mitomycin C or doxorubicin
                  within 6 weeks and latest usage of antibody antitumor biologics within 4 weeks.

              14. Participants with current or prior retinal detachment or presently confirmed
                  diagnosis keratopathy including but not limited to bullous keratopathy, calcific
                  band keratopathy, corneal abrasion, keratohelcosis, keratitis and so on.

              15. Participants with history of autoimmune disease.

              16. Pregnant or nursing women.

              17. Participants who, in the judgment of the investigator, will be unfit for the
                  study. ( For reasons such as poor compliance, unsuitable for venous
                  catheterization and so on)
      

Gender

All

Ages

18 Years - 75 Years

Accepts Healthy Volunteers

No

Contacts

, +862087343333, [email protected]

Location Countries

China

Location Countries

China

Administrative Informations


NCT ID

NCT03734926

Organization ID

ZSP1241-18-01


Responsible Party

Sponsor

Study Sponsor

Guangdong Zhongsheng Pharmaceutical Co., Ltd.


Study Sponsor

, , 


Verification Date

July 2020