OncoMatch/Clinical Trials/NCT05187182
CA-4948 in Combination With FOLFOX/PD-1 Inhibitor +/- Trastuzumab for Untreated Unresectable Gastric and Esophageal Cancer
Is NCT05187182 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments for gastric cancer.
Treatment: CA-4948 · Nivolumab · Pembrolizumab · Trastuzumab · mFOLFOX7 — This is a phase I trial of CA-4948 in combination with FOLFOX/PD-1 inhibitor with or without trastuzumab for unresectable gastric, GEJ, and esophageal cancer. During the Dose Escalation portion of the study, different dose levels of CA-4948 in combination with FOLFOX/nivolumab will be evaluated by BOIN algorithm. Dose Expansion will include Cohorts A and B. Expansion Cohort A will enroll up to 12 patients with HER2 negative gastric, GEJ, and esophageal cancer at the expansion dose of CA-4948 determined during Dose Escalation and will use the same treatment regimen of FOLFOX/nivolumab. Expansion Cohort B will investigate CA-4948 at the dose determined during Dose Escalation in combination with FOLFOX/pembrolizumab and trastuzumab in up to 12 patients with HER2 positive disease; however, the initial 6 patients will be considered safety lead-in to confirm the safety and tolerability of this combination; if determined to be safe, an additional 6 patients will be enrolled for a total of 12 in Cohort B.
Check if I qualifyExtracted eligibility criteria
Cancer type
Gastric Cancer
Esophageal Carcinoma
Biomarker criteria
Required: HER2 (ERBB2) negative
For Dose Escalation, patients are required to have documented HER2 negative cancer.
Allowed: HER2 (ERBB2) positive
For Dose Expansion, patients will be enrolled to either HER2 positive or negative cohorts at the time of enrollment
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: systemic therapy
Exception: Neoadjuvant or adjuvant systemic therapy is allowed if surgical resection and adjuvant chemotherapy > 3 months from planned C1D1; up to two prior cycles of FOLFOX is allowed; definitive chemoradiation allowed if last date of chemotherapy or radiation > 3 months from planned C1D1; prior palliative radiation therapy allowed if last treatment >10 days from planned C1D1.
No prior systemic treatment for unresectable/advanced gastric, GEJ, or esophageal cancer.
Lab requirements
Blood counts
Absolute neutrophil count ≥ 1.5 K/cumm; Platelets ≥ 100 K/cumm; Hemoglobin ≥ 9.0 g/dL
Kidney function
Creatinine clearance ≥ 35 mL/min by Cockcroft-Gault
Liver function
Total bilirubin ≤ 1.5 x IULN or ≤ 3 x IULN in patients with documented Gilbert's syndrome; AST(SGOT)/ALT(SGPT) ≤ 2.0 x IULN, unless there are liver metastases in which case AST and ALT ≤ 5.0 x IULN; PT/INR ≤ 1.5 x IULN; aPTT ≤ 1.5 x IULN
Cardiac function
Expansion Cohort B patients only: LVEF above LLN as assessed by MUGA or ECHO; QTc (Bazett) ≤ 470ms on screening EKG
Adequate bone marrow and organ function as defined below: ... Expansion Cohort B patients only: LVEF above LLN as assessed by MUGA or ECHO; QTc (Bazett) >470ms on screening EKG [excluded]
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Washington University School of Medicine · St Louis, Missouri
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify