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

Sponsor: Crescent Biopharma, Inc.

Sponsor score: 0

ClinicalTrials ID:NCT07335497

This study evaluates the safety and tolerability of CR-001 in adults with advanced solid tumors through dose escalation, backfill, and dose optimization. Eligible participants have specific tumor types and meet inclusion criteria. Exclusions include recent malignancies, CNS metastases, and severe infections. CR-001 is administered via intravenous infusion.

Patient Parameters

Program Overview

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.

Description

The study will initially comprise 3 parts: dose escalation, backfill, and dose optimization cohorts. The study will follow a stepwise approach, beginning with a typical dose escalation in participants with selected indications of advanced solid tumors. Additional participants will enroll in the backfill part at select dose levels that have been previously cleared for safety by the safety review committee. In dose optimization, participants will be randomized to one of two CR-001 dose levels.

All participants will undergo a screening period, a treatment period of up to 2 years, a safety follow-up period, and long-term efficacy and survival follow-up. During the treatment period, participants will undergo clinical and safety assessments including disease assessment scans and blood laboratory safety, pharmacokinetic, and pharmacodynamic assessments. After treatment ends, disease scans will continue until disease progression, and long-term follow-up visits will be conducted by telephone every 3 months.

Eligibility Criteria

Inclusion Criteria

  • For dose escalation or backfill: progressing from, intolerant to, or ineligible for (due to unavailability or contraindication) local standard of care therapies and have one of the following locally advanced or metastatic tumor types:

    • Hepatocellular carcinoma
    • Biliary tract cancer
    • Endometrial carcinoma
    • Cervical cancer
    • Ovarian cancer
    • Gastric or gastroesophageal cancer
    • Colorectal cancer
    • Non-small cell lung cancer

Key Exclusion Criteria

  • Has malignancies other than disease under study within the past 3 years
  • Has conditions requiring treatment with clinically significant or increasing doses of systemic steroid therapy
  • Has not adequately recovered from recent major surgery
  • Has ongoing clinically significant toxicity related to prior therapy
  • Has active central nervous system (CNS) metastases
  • Has active autoimmune disease requiring systemic therapy in the past 2 years (replacement therapy is permitted)
  • Has a history of serious Grade ≥ 3 immune-related adverse event (irAE)
  • Has a history of noninfectious pneumonitis/interstitial lung disease
  • Has an active severe infection
  • Has received a live or attenuated vaccine within 30 days of the first dose
  • Has undergone prior allogeneic stem cell or solid organ transplantation
  • Has protocol-specified events related to gastrointestinal perforation, surgery, wound healing complications, and bleeding
  • Has clinically significant cardiovascular disease NOTE: Other protocol defined Inclusion and Exclusion criteria may apply.

Locations

FACILITYZIPCITYSTATE
Clinical Study Site80218DenverColorado
Clinical Study Site32827OrlandoFlorida
Clinical Study Site34236SarasotaFlorida
Clinical Study Site49546Grand RapidsMichigan
Clinical Study Site43210ColumbusOhio
Clinical Study Site37203NashvilleTennessee
Clinical Study Site75230DallasTexas
Clinical Study Site78229San AntonioTexas
Clinical Study Site84119West Valley CityUtah

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