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

NCT04798781 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: IIT2020-11-Hendifar-TELAT
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Gastric Cancer; Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (1)

• Progression-free Survival

  Duration of time from start of treatment until progression or death, whichever comes first

  through study completion, approximately 2.5 years

Secondary Outcomes (4)

• Overall Response Rate

  from the start of treatment until the end of treatment, approximately 12 months

• Disease Control Rate

  from the start of treatment until the end of treatment, approximately 12 months

• Overall Survival

  from the start of treatment until time-of-event

• Number and Severity of Adverse Events

  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

Study Arms (1)

telatinib + Keytruda

EXPERIMENTAL

Drug: Telatinib; Drug: Keytruda

Interventions

Telatinib DRUG

900mg by mouth twice daily until disease progression, intolerable toxicities, or withdrawal of consent

telatinib + Keytruda

Keytruda DRUG

200mg intravenous infusion every three weeks until disease progression, intolerable toxicities, or withdrawal of consent

Also known as: pembrolizumab

telatinib + Keytruda

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 and/or discontinued second line therapy for intolerance, indicated for Keytruda therapy. OR: Hepatocellular carcinoma with diagnosis confirmed by histologic or cytologic analysis or clinical features according to the American Association for the Study of Liver Diseases criteria for patients with cirrhosis, unresectable disease not amenable to locoregional therapy with disease progression after at least one prior line of systemic therapy or discontinued first line therapy for intolerance.
• 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.
• Eastern Cooperative Oncology Group (ECOG) performance score of 0, 1 or 2.
• 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 and agree to take the prescribed tablets twice daily.

You may not qualify if:

• 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. HIV-infected subjects on effective anti-retroviral therapy are eligible if the most recent viral load test performed within six months of screening (based on medical chart review) is negative. The safety of telatinib in this subject population has not been studied.
• Known chronic hepatitis B, unless receiving antiviral treatment.
• Known Child-Pugh Score B or C liver cirrhosis.
• 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.

Sponsors & Collaborators

• Andrew Hendifar, MD: lead
• EOC Pharma: collaborator

Study Sites (3)

CS Cancer Beverly Hills

Beverly Hills, California, 90211, United States

Location

CS Cancer at The Angeles Clinic and Research Institute

Los Angeles, California, 90025, United States

Location

CS Cancer at the Samuel Oschin Cancer Center

Los Angeles, California, 90048, United States

Location

MeSH Terms

Conditions

Stomach Neoplasms; Carcinoma, Hepatocellular

Interventions

telatinib; pembrolizumab

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Liver Neoplasms; Liver Diseases

Results Point of Contact

• Title: Andrew Hendifar, MD, MPH
• Organization: Cedars-Sinai Medical Center

andrew.hendifar@cshs.org

3104232217

Study Officials

• Andrew Hendifar, MD, MPH

  Cedars-Sinai Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor, Medicine

Study Record Dates

• First Submitted: February 24, 2021
• First Posted: March 15, 2021
• Study Start: July 28, 2021
• Primary Completion: February 14, 2024
• Study Completion: October 20, 2025
• Last Updated: December 11, 2025
• Results First Posted: October 10, 2024

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)