Skip to content
DataLookout
Start free
Menu

APOLLONCT07909031

CR-002 in Adult Participants With Locally Advanced or Metastatic Solid Tumors

StatusRecruiting
PhasePhase 1/2
Primary completion (estimated)
Track this trial

Free. We email you which fields changed when ClinicalTrials.gov updates this record.

Record History

All 1 version: 1 with changes below.

  1. Study First Submitted

Endpoints

Primary

Part 1: Dose Escalation - incidence and nature of dose-limiting toxicities
Timeframe: From the first dose of study drug up until approximately 1 month
Part 1: Dose Escalation - characterization of the maximum tolerated dose, if applicable
Timeframe: From the first dose of study drug up until approximately 1 month
All Parts - incidence, nature, and severity of treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events
Timeframe: 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 dose modifications
Timeframe: 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
Timeframe: From the first dose of study drug until 90 days after the last dose of study drug

Secondary (11)

All Parts - determination of recommended phase 2 dose(s)
All Parts - serum CR-002 pharmacokinetic parameters
All Parts - incidence of participants with detectable antidrug antibodies
All Parts - overall response rate (ORR)
All Parts - duration of response (DOR)
Show 6 moreShow less
All Parts - disease control rate (DCR)
All Parts - clinical benefit rate (CBR)
All Parts - time to response (TTR)
All Parts - progression free survival (PFS)
All Parts - overall survival (OS)
All Parts - best percent change in target lesions

Arms and interventions

CR-002 Dose EscalationExperimental

Escalating 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 BackfillExperimental

Escalating dose levels of CR-002 will be tested in indication-specific cohort populations.

Drugs: CR-002

Sites

3 sites in 1 country