Clinical Trials /

Safety and Efficacy of Telatinib in Combination With Keytruda in Subjects With Advanced Stomach and Gastroesophageal Junction Cancers or Hepatocellular Carcinoma

NCT04798781

Description:

This is a phase II, single arm, open-label study of two parallel cohorts (advanced stomach and gastroesophageal junction cancer and hepatocellular carcinoma), evaluating the effects of telatinib in combination with Keytruda on progression-free survival.

Related Conditions:
  • Adenocarcinoma of the Gastroesophageal Junction
  • Esophageal Adenocarcinoma
  • Gastric Adenocarcinoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Safety and Efficacy of Telatinib in Combination With Keytruda in Subjects With Advanced Stomach and Gastroesophageal Junction Cancers or Hepatocellular Carcinoma
  • Official Title: A Phase II Study Evaluating Safety and Efficacy of Telatinib in Combination With Keytruda in Subjects With Advanced Stomach and Gastroesophageal Junction Cancers or Hepatocellular Carcinoma

Clinical Trial IDs

  • ORG STUDY ID: IIT2020-11-Hendifar-TELAT
  • NCT ID: NCT04798781

Conditions

  • Gastric Cancer
  • Hepatocellular Carcinoma

Interventions

DrugSynonymsArms
Telatinibtelatinib + Keytruda
Keytrudapembrolizumabtelatinib + Keytruda

Purpose

This is a phase II, single arm, open-label study of two parallel cohorts (advanced stomach and gastroesophageal junction cancer and hepatocellular carcinoma), evaluating the effects of telatinib in combination with Keytruda on progression-free survival.

Trial Arms

NameTypeDescriptionInterventions
telatinib + KeytrudaExperimental
  • Telatinib
  • Keytruda

Eligibility Criteria

        Inclusion Criteria:

          -  Diagnosis: Histologically confirmed gastric/esophagealgastric adenocarcinoma,
             recurrent, locally advanced or metastatic, PD-L1-positive disease (CPS ≥1), progressed
             on at least two prior lines of therapy, indicated for Keytruda therapy. OR:
             Histologically confirmed hepatocellular carcinoma, unresectable disease not amenable
             to locoregional therapy with disease progression after at least one prior line of
             systemic therapy.

          -  At least 1 measurable metastatic lesion that has not been irradiated. The lesion will
             be measured according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1),
             and be documented by radiological evaluation within 28 days prior to registration. For
             subjects with locally advanced disease: at least one measurable lesion that has not
             been irradiated, documented by radiological evaluation within 28 days prior to
             registration.

          -  Any prior radiation therapy must be completed at least 28 days prior to the first dose
             of study treatment.

          -  Eighteen years of age or older.

          -  Adequate bone marrow, liver, and renal function

          -  Negative urine or serum pregnancy test for women of childbearing potential.

          -  Women and men of childbearing potential must agree to use adequate contraception prior
             to registration, for the duration of study participation and until 4 months after the
             last study drug dosing.

          -  Able to swallow tablets.

        Exclusion Criteria:

          -  Clinical or radiographic evidence of current brain metastasis. History of treated
             brain metastases is allowable.

          -  Cardiac disease

          -  Uncontrolled hypertension

          -  Severe hemorrhage/bleeding event within 28 days prior to the first dose of study
             treatment

          -  Major surgery, open biopsy, or significant traumatic injury within 42 days prior to
             the first dose of study treatment

          -  Current serious, nonhealing wound, ulcer, or bone fracture within 42 days prior to the
             first dose of study treatment

          -  History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess
             within 6 months prior to the first dose of study treatment.

          -  Presence of an uncontrolled infection or infection that required intravenous
             antibiotics, antifungals, or antivirals within 14 days prior to the first dose of
             study treatment.

          -  Known human immunodeficiency virus (HIV) infection or chronic hepatitis B or C. The
             safety of telatinib in this subject population has not been studied.

          -  Diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other
             form of immunosuppressive therapy within 7 days prior to the first dose of study
             treatment or has been diagnosed with an autoimmune disease that has required systemic
             treatment in the past 2 years (i.e., with use of disease modifying agents,
             corticosteroids, or immunosuppressive drugs). Patients that require replacement
             therapy (e.g., thyroxine [T4], insulin, or physiologic corticosteroid replacement
             therapy for adrenal or pituitary insufficiency, etc.) may be enrolled.

          -  History of (non-infectious) pneumonitis that required steroids, or current
             pneumonitis, or has a history of interstitial lung disease.

          -  Has received a live-virus vaccination within 30 days of planned treatment start.

          -  Known history of proteinuria > 1gr/24 hours.

          -  Previous or concurrent cancer that is distinct in primary site or histology from the
             current stomach or liver cancer. Subjects with cervical cancer in-situ, treated basal
             cell carcinoma, superficial bladder tumors (Ta and Tis) or any cancer curatively
             treated are not excluded.

          -  Anti-cancer therapy (chemotherapy, hormonal therapy, radiation therapy, surgery,
             immunotherapy, biologic therapy, or tumor embolization) or investigational agent
             within 28 days prior to the first dose of study treatment.

          -  Known or suspected allergy to any component of telatinib or Keytruda

          -  Prior or current history of substance abuse, or medical, psychological, or social
             condition that in the opinion of the investigator may interfere with the subject's
             participation in the study or evaluation of the study result.

          -  Women who are pregnant or breastfeeding.

          -  Prior history of thromboembolic disease, e.g., deep vein thrombosis (DVT), pulmonary
             emboli (PE), within 6 months prior to the first dose of study treatment that has
             required continued medical intervention.

          -  Baseline peripheral neuropathy.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Progression-free survival
Time Frame:from the start of treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 10 years
Safety Issue:
Description:Duration of time from start of treatment until progression or death, whichever comes first

Secondary Outcome Measures

Measure:Overall response rate
Time Frame:from the start of treatment until the end of treatment, approximately 12 months
Safety Issue:
Description:The percentage of patients who have a partial or complete response to treatment
Measure:Disease control rate
Time Frame:from the start of treatment until the end of treatment, approximately 12 months
Safety Issue:
Description:The percentage of patients who have stable disease, partial response, or complete response to treatment
Measure:Overall survival
Time Frame:from the start of treatment until the end of follow-up, approximately 18 months
Safety Issue:
Description:The length of time from the start of treatment that patients are still alive
Measure:Incidence and severity of adverse events
Time Frame:from the start of treatment until 30 days following the end of treatment or until initiation of a new anticancer therapy (whichever occurs first), approximately 13 months
Safety Issue:
Description:Incidence and severity of adverse events as measured by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Andrew Hendifar, MD

Last Updated

August 4, 2021