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Study of ISM5939 in Patients With Advanced and/or Metastatic Solid Tumors

NCT06724042 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 159

Last updated 2025-12-10

No results posted yet for this study

Summary

This is a first-in-human Phase 1a/b, open-label, multicenter, dose escalation, optimization and expansion study of ISM5939 to evaluate the safety, tolerability, PK, PD, and preliminary antitumor activity of ISM5939 in patients with advanced or metastatic solid tumors.

The study will be conducted in 3 parts sequentially: Part 1 dose escalation ISM5939 monotherapy, Part 2 dose optimization to determine RP2D of ISM5939 monotherapy, and Part 3 dose expansion in 3 cohorts after initial safety run-in of ISM5939 combination therapy.

Conditions

  • Advanced Solid Tumor
  • Metastatic Solid Tumor
  • Advanced and/or Metastatic Solid Tumors

Interventions

DRUG

Cisplatin

Cisplatin will be administered intravenously in combination with ISM5939 on day 1 during each cycle.

DRUG

Docetaxel

Docetaxel will be administered intravenously in combination with ISM5939 on day 1 during each cycle.

DRUG

Pembrolizumab

Pembrolizumab will be administered intravenously in combination with ISM5939 on day 1 during each cycle.

DRUG

ISM5939

ISM5939 tablets will be administered orally once daily (QD).

Sponsors & Collaborators

  • InSilico Medicine Hong Kong Limited

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-30
Primary Completion
2029-06-30
Completion
2030-06-30
FDA Drug
Yes

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Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06724042 on ClinicalTrials.gov