Study of ISM3412 in Participants With Locally Advanced/Metastatic Solid Tumors

Conditions

• Locally Advanced/Metastatic Solid Tumors

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• ISM3412 — DRUG
  ISM3412 will be administered orally once daily.

Study Details

The study has consists of two parts, a dose escalation part (Part 1) and a dose selection optimization part (Part 2). The primary objectives of this study are to evaluate the safety and tolerability of ISM3412 in participants with locally advanced/metastatic solid tumors, and to determine the RP2D of ISM3412.

Key Dates

Start date

Apr 25, 2025

Status verified

Nov 2025

Primary completion

Mar 31, 2028

Completion

Mar 31, 2029

Study Design

Enrollment

80 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: Part 1 Dose Escalation
  Patients will receive ISM3412 once daily in sequential cohorts of increasing doses.
• Experimental: Part 2 Dose Selection Optimization
  Participants will be randomized to receive one of the two selected dose levels of ISM3412 once daily determined by Study Review Committee.

Primary Outcome Measure

Incidence of dose-limiting toxicity (DLT) events [ Time Frame: 31 days ]

Central Contacts

• Rebecca Griffith
  +86 021-50831718
  [email protected]
• Rebecca Griffith
  +1 (254) 265-2782

Locations (5)

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