Health TrialsbyHealthPanel

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

ConditionLocally Advanced / Metastatic Solid Tumors
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorCrescent Biopharma, Inc.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Sequential

Treatments tested in this trial

  • CR-001

    Drug

    Intravenous Infusion

Treatment groups

290 Participants
are divided into 4 treatment groups
Group A: CR-001 Dose escalationExperimental treatment 1 intervention
Group B: CR-001 BackfillExperimental treatment 1 intervention
Group C: CR-001 Dose Optimization Cohort XExperimental treatment 1 intervention
Group D: CR-001 Dose Optimization Cohort YExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Dose Escalation - Incidence and nature of dose-limiting toxicities

Per cohort

Time frame
From the first dose of study drug up until approximately 1 month
2

Dose Escalation - Characterization of the maximum tolerated dose, if applicable

Per Cohort

Time frame
From the first dose of study drug up until approximately 1 month
3

All parts - Incidence, nature, and severity of treatment emergent adverse events (TEAEs) and treatment - emergent serious adverse events

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

Time frame
From the first dose of study drug until 90 days after the last dose of study drug
4

All parts - Incidence and severity of TEAEs leading to dose modifications

Time frame
From the first dose of study drug until 90 days after the last dose of study drug

Secondary outcomes

1

All parts - Determination of recommended Phase 2 dose(s)

Time frame
From the first dose of study drug until 90 days after the last dose of study drug
2

All parts - Serum CR-001 pharmacokinetic parameters

AUC0--inf after a single dose and steady state parameters, as appropriate

Time frame
Predose until up to approximately 36 months
3

All parts - Serum CR-001 pharmacokinetic parameters

AUClast after a single dose and steady state parameters, as appropriate

Time frame
Predose until up to approximately 36 months
4

All parts - Serum CR-001 pharmacokinetic parameters

Cmax after a single dose and steady state parameters, as appropriate

Time frame
Predose until up to approximately 36 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Crescent Biopharma, Inc.

Lead sponsor

Source ClinicalTrials.gov
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