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.
- 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
- 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
- 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.
- 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
- 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
- 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.