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

RecruitingPhase 1, Phase 2Ages 18 Years - anyAllCrescent Biopharma, Inc.
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Key Inclusion Criteria * Life expectancy โ‰ฅ 3 months * Eastern Cooperative Oncology Group (ECOG) performance status score of 0 - 1 * Adequate organ function and hematologic reserve based on laboratory parameters * Have measurable disease defined by RECIST v1.1 * For Backfill, Dose Expansion and Dose Optimization: Willingness to provide recent archival tumor tissue sample or willingness to undergo biopsy * Tumor Indication specific 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: * Non-small cell lung cancer (NSCLC) * Hepatocellular carcinoma (HCC) * Biliary tract cancer (BTC) * Endometrial carcinoma * Cervical cancer * Ovarian cancer * Gastric or gastroesophageal cancer (GC/GEJ) * Colorectal cancer (CRC) * For dose expansion: have one of the following locally advanced or metastatic tumor types: * 1L Non-small cell lung cancer (NSCLC) * 1L Colorectal cancer (CRC) * 3L Colorectal cancer (CRC) * 1L Endometrial carcinoma * 1L Gastric or gastroesophageal cancer (GC/GEJ) * 2L Gastric or gastroesophageal cancer (GC/GEJ) * 1L Biliary tract cancer (BTC) Key Exclusion Criteria for all parts * 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 โ‰ฅ 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 Key Exclusion Criteria for dose expansion only * Has received prior anti-PD-1/L1 treatment * Has history of hypersensitivity reaction to the cohort-specific combination agent(s) or its excipients * Has any contraindication to the cohort-specific combination agent(s) * Has Grade \>1 neuropathy at Screening NOTE: Other protocol defined Inclusion and Exclusion criteria may apply.
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What it tests

  • CR-001
  • Paclitaxel
  • trifluridine and tipiracil
  • Pemetrexed
  • Carboplatin
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Where

34 sites
Clinical Study Site
Birmingham, United States
Clinical Study Site
Los Angeles, United States
Clinical Study Site
Denver, United States
Clinical Study Site
Washington D.C., United States
Clinical Study Site
Orlando, United States
Clinical Study Site
Sarasota, United States
Clinical Study Site
Detroit, United States
Clinical Study Site
Grand Rapids, United States

โ€ฆand 26 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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