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002

Phase 1/2

Head and Neck Squamous Cell Carcinoma (HNSCC) - Recurrent/Metastatic (R/M) | Small Molecules | Oncology |Crescent Biopharma, Inc.|Trials Updated: Nov 2, 2026

002 target and mechanism

ModalitySmall Molecules

Also known as CR-002

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment219

FDA Designations

No designations recorded

002 clinical trials

002 · 1 trial · 8 indications

Phase 1/2 1
NCT07909031CR-002 in Adult Participants With Locally Advanced or Metastatic Solid TumorsHead and Neck Squamous Cell Carcinoma (HNSCC) - Recurrent/Metastatic (R/M)
RECRUITING219 Analytics
PHASE1/PHASE2RECRUITING
CR-002 in Adult Participants With Locally Advanced or Metastatic Solid Tumors
Head and Neck Squamous Cell Carcinoma (HNSCC) - Recurrent/Metastatic (R/M)
NCT07909031219
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Study Endpoints

Primary Endpoints

Part 1: Dose Escalation - incidence and nature of dose-limiting toxicities
From the first dose of study drug up until approximately 1 month

Per cohort

Part 1: Dose Escalation - characterization of the maximum tolerated dose, if applicable
From the first dose of study drug up until approximately 1 month

Per cohort

All Parts - incidence, nature, and severity of treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events
From the first dose of study drug until 90 days after the last dose of study drug

Events are graded according to National Cancer Institute Cancer Terminology Criteria for Adverse Events (NCI CTCAE)

All Parts - incidence and severity of TEAEs leading to dose modifications
From the first dose of study drug until 90 days after the last dose of study drug
All Parts - incidence and severity of TEAEs leading to treatment discontinuation
From the first dose of study drug until 90 days after the last dose of study drug

Secondary Endpoints

All Parts - determination of recommended phase 2 dose(s)
From the first dose of study drug until 90 days after the last dose of study drug
All Parts - serum CR-002 pharmacokinetic parameters
Predose until up to approximately 36 months
All Parts - incidence of participants with detectable antidrug antibodies
Predose until up to approximately 36 months
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
CR-002 Dose EscalationEXPERIMENTALEscalating dose levels of CR-002 will be tested to define the maximum tolerated dose of CR-002 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.
CR-002 BackfillEXPERIMENTALEscalating dose levels of CR-002 will be tested in indication-specific cohort populations.

Interventions

NameTypeDescription
CR-002DRUGIntravenous Infusion
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites3

Inclusion Criteria: * Life expectancy ≥ 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 * Willingness to provide recent archival t...

Countries:United States
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Recent Changes (Last 90 Days)

LOWNov 2, 2026NCT07909031NEW_TRIAL: changed
LOWNov 2, 2026NCT07909031NEW_TRIAL: changed

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