A Phase I/II, Multicenter, Open-label, Dose Escalation and Dose Expansion Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Antitumor Activity of CR-001 in Adult Participants With Locally Advanced or Metastatic Solid Tumors
Study Identifier:
CR-001-101
CT.gov Identifier:
EudraCT Identifier:
EU Trial (CTIS) Number:
Study Contact Information:
Recruiting
Considering participating in a START clinical trial?
Study Summary
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.
To evaluate CR-001 in multiple solid tumor types, including NSCLC, gastrointestinal and gynecological cancers in first-line and previously treated patients
To evaluate the safety and antitumor activity of CR-001 in adults with locally advanced or metastatic solid tumors.
The purpose of this study is to determine the safety and tolerability of CR-001 and identify the maximum tolerated dose, and/or recommended phase 2 dose.
Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
Bowel (Colorectal)
Non-Small Cell Lung Cancer
Ovarian
Gastric
Liver
Solid Tumor
Endometrial
Cervical cancer
Bile Duct
Phase
The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
Phase I/II
Sex
Female & Male
Age
18+ years
Study Drug
N/A
Study Status
Indicates the current recruitment status or the expanded access status
Recruiting
Requirements information
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
- 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
- For Backfill 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:
- Hepatocellular carcinoma
- Biliary tract cancer
- Endometrial carcinoma
- Cervical cancer
- Ovarian cancer
- Gastric or gastroesophageal cancer
- Colorectal cancer
- Non-small cell lung cancer
- Life expectancy ≥ 3 monthsEastern Cooperative Oncology Group (ECOG) performance status score of 0 - 1Adequate organ function and hematologic reserve based on laboratory parametersHave measurable disease defined by RECIST v1.1For Backfill, Dose Expansion and Dose Optimization: Willingness to provide recent archival tumor tissue sample or willingness to undergo biopsyTumor 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 carcinomaCervical cancerOvarian cancerGastric 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 carcinoma1L Gastric or gastroesophageal cancer (GC/GEJ)2L Gastric or gastroesophageal cancer (GC/GEJ)1L Biliary tract cancer (BTC)
Exclusion criteria
- Has malignancies other than disease under study within the past 3 yearsHas conditions requiring treatment with clinically significant or increasing doses of systemic steroid therapyHas not adequately recovered from recent major surgeryHas ongoing clinically significant toxicity related to prior therapyHas active central nervous system (CNS) metastasesHas 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 diseaseHas an active severe infectionHas received a live or attenuated vaccine within 30 days of the first doseHas undergone prior allogeneic stem cell or solid organ transplantationHas protocol-specified events related to gastrointestinal perforation, surgery, wound healing complications, and bleedingHas clinically significant cardiovascular diseaseKey Exclusion Criteria for dose expansion only
- Has received prior anti-PD-1/L1 treatmentHas history of hypersensitivity reaction to the cohort-specific combination agent(s) or its excipientsHas 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.
Clinical Study Information for Healthcare Providers
By clicking the button below you will find in-depth information about this clinical trial, including study design, primary and secondary endpoints, and more. This information is intended for healthcare professionals seeking to review the scientific and operational aspects of the study.
Study Locations
Location
Investigator
Status
Condition(s) Treated at Site
Location
START Barcelona
Barcelona, Spain, 08023
Investigator
Tatiana Hernandez Guerrero
Status
Recruiting
Condition(s) Treated at Site
Bowel (Colorectal)
Non-Small Cell Lung Cancer
Ovarian
Gastric
Liver
Solid Tumor
Endometrial
Cervical cancer
Bile Duct
Location
START Dublin
Dublin, Ireland, D07 R2WY
Investigator
Austin Duffy
Status
Recruiting
Condition(s) Treated at Site
Bowel (Colorectal)
Non-Small Cell Lung Cancer
Ovarian
Gastric
Liver
Solid Tumor
Endometrial
Cervical cancer
Bile Duct
Location
START Madrid, Spain (FJD)
Madrid, Spain, 28040
Investigator
Victor Moreno Garcia
Status
Recruiting
Condition(s) Treated at Site
Bowel (Colorectal)
Non-Small Cell Lung Cancer
Ovarian
Gastric
Liver
Solid Tumor
Endometrial
Cervical cancer
Bile Duct
Location
START Mountain Region
West Valley City, UT, United States, 84119
Investigator
Justin Call
Status
Recruiting
Condition(s) Treated at Site
Bowel (Colorectal)
Non-Small Cell Lung Cancer
Ovarian
Gastric
Liver
Solid Tumor
Endometrial
Cervical cancer
Bile Duct
Location
START Midwest
Grand Rapids, MI, United States, 49546
Investigator
Nehal Lakhani
Status
Recruiting
Condition(s) Treated at Site
Bowel (Colorectal)
Non-Small Cell Lung Cancer
Ovarian
Gastric
Liver
Solid Tumor
Endometrial
Cervical cancer
Bile Duct
Location
START La Rioja
Logroño, La Rioja, Spain, 26006
Investigator
Maria Jose de Miguel Luken
Status
Recruiting
Condition(s) Treated at Site
Bowel (Colorectal)
Non-Small Cell Lung Cancer
Ovarian
Gastric
Liver
Solid Tumor
Endometrial
Cervical cancer
Bile Duct
Go to page