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

Sponsor
InSilico Medicine Hong Kong Limited
Study ID
NCT06724042
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • ISM5939 — DRUG
    ISM5939 tablets will be administered orally once daily (QD).
  • Cisplatin — DRUG
    Cisplatin will be administered intravenously in combination with ISM5939 on day 1 during each cycle.
  • Docetaxel — DRUG
    Docetaxel will be administered intravenously in combination with ISM5939 on day 1 during each cycle.
  • Pembrolizumab — DRUG
    Pembrolizumab will be administered intravenously in combination with ISM5939 on day 1 during each cycle.

Study Details

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.

Key Dates

Start date
Jun 30, 2026
Status verified
Dec 2025
Primary completion
Jun 30, 2029
Completion
Jun 30, 2030

Study Design

Enrollment
159 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Part 1 Dose escalation
    An open-label dose escalation of ISM5939 administered orally as a single agent in patients with advanced or metastatic solid tumors.
  • Experimental: Part 2 Dose optimization
    ISM5939 will be administered orally as a single agent in patients with advanced or metastatic solid tumors in 2 selected dose levels to determine RP2D of ISM5939 monotherapy.
  • Experimental: Part 3 Dose expansion
    This will be an open-label evaluation of ISM5939 administered orally in combination with cisplatin, docetaxel, or pembrolizumab in patients with selected advanced solid tumors. Each of the combination cohort will start with safety run-in dose escalation for ISM5939. Subsequent subjects will then be enrolled in combination expansion cohorts with a fixed dose of ISM5939 selected by safety review committee.

Primary Outcome Measure

Dose-limiting toxicities (DLTs) occurrence [ Time Frame: Day 1 up to Day 28 for Part 1 and Day 1 up to Day 21 for Part 3 safety run-in dose escalation period ]

Central Contacts

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