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OncoMatch/Clinical Trials/NCT06783569

A First-in-Human Escalation and Expansion Study of Patients With Advanced Solid Tumors

Is NCT06783569 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies JR8603 for solid tumors.

Phase 1RecruitingJiaRay GroupNCT06783569Data as of May 2026

Treatment: JR8603The goal of this clinical trial is to learn if the investigational drug (JR8603) is safe and effective in treating patients with solid tumors after their initial rounds of treatment with other drugs did not work.

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Extracted eligibility criteria

Cancer type

Tumor Agnostic

Gastric Cancer

Colorectal Cancer

Biomarker criteria

Allowed: HER2 (ERBB2) positive

HER2-positive gastric or EGJ cancer

Allowed: HER2 (ERBB2) negative

HER2-negative gastric or EGJ cancer

Allowed: MMR deficient

MMR-deficient (dMMR)/microsatellite instability-high (MSI-H)

Allowed: MMR proficient

proficient mismatch repair (pMMR)

Allowed: BRAF wild-type

RAS and BRAF wild-type (WT)

Allowed: KRAS wild-type

RAS and BRAF wild-type (WT)

Allowed: BRAF mutation

BRAF mutation

Allowed: KRAS mutation

RAS mutation

Disease stage

Required: Stage III, IV

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

Must have received: systemic standard therapy — all

which has progressed on, or patients intolerant to, all standard therapy, or no standard therapy available, or it is documented that the therapy is refused by the patient

Cannot have received: systemic anticancer chemotherapy, targeted agents, antibody therapy for cancer, immunotherapy for cancer, hormonal therapy, or an investigational agent

Received systemic anticancer chemotherapy, targeted agents, antibody therapy for cancer, immunotherapy for cancer, hormonal therapy, or an investigational agent within 2 weeks or 5 half-lives (whichever is shorter) prior to start of study drug treatment

Lab requirements

Blood counts

ANC ≥1.5 × 10^9/L (≥1500/mm3); Platelet count ≥100 × 10^9/L (≥100,000/mm3) (no platelet transfusion within 14 days prior to enrollment)

Kidney function

Estimated creatinine clearance by Cockcroft-Gault or eGFR ≥60 mL/min

Liver function

Total bilirubin ≤1.5 × ULN, unless known Gilbert syndrome (≤3 × ULN); AST and ALT ≤2.5 × ULN or ≤5 × ULN for patients with known liver metastases

Cardiac function

INR, PT, and aPTT ≤1.5 × ULN. If receiving anticoagulant therapy, PT and aPTT must be within therapeutic range of intended use of anticoagulants

Adequate organ and bone marrow function defined by: ANC ≥1.5 × 10^9/L (≥1500/mm3); Platelet count ≥100 × 10^9/L (≥100,000/mm3) (no platelet transfusion within 14 days prior to enrollment); Total bilirubin ≤1.5 × ULN, unless known Gilbert syndrome (≤3 × ULN); AST and ALT ≤2.5 × ULN or ≤5 × ULN for patients with known liver metastases; Estimated creatinine clearance by Cockcroft-Gault or eGFR ≥60 mL/min; INR, PT, and aPTT ≤1.5 × ULN. If a patient is receiving anticoagulant therapy, PT and aPTT must be within therapeutic range of intended use of anticoagulants

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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