CR-001 in Adult Participants With Locally Advanced or Metastatic Solid Tumors

Conditions

• Locally Advanced / Metastatic Solid Tumors

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• CR-001 — DRUG
  Intravenous Infusion

Study Details

The purpose of this study is to determine the safety and tolerability of monotherapy CR-001 and identify the maximum tolerated dose (MTD), and/or optimal biologic dose and Recommended Phase 2 Dose(s) (RP2D) in participants with locally advanced or metastatic solid tumors.

Key Dates

Start date

Feb 17, 2026

Status verified

May 2026

Primary completion

Feb 28, 2029

Completion

Feb 28, 2029

Study Design

Enrollment

290 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: CR-001 Dose escalation
  Escalating dose levels of CR-001 to define the maximum tolerated dose of CR-001 in participants with locally advanced or metastatic solid tumors who are refractory to or unable to tolerate standard of care treatment, or for whom standard of care treatment is unavailable
• Experimental: CR-001 Backfill
  Escalating dose levels of CR-001 Indication-specific cohort populations will be tested
• Experimental: CR-001 Dose Optimization Cohort X
  monotherapy dose level (DL)-X Indication-specific cohort populations will be tested
• Experimental: CR-001 Dose Optimization Cohort Y
  monotherapy DL-Y Indication-specific cohort populations will be tested

Primary Outcome Measure

Dose Escalation - Incidence and nature of dose-limiting toxicities [ Time Frame: From the first dose of study drug up until approximately 1 month ]

Central Contacts

• Crescent Clinical Trials
  617-430-5595
  [email protected]

Locations (9)

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