CompletedPhase 1

Study of STRO-002, an Anti-Folate Receptor Alpha (FolRα) Antibody Drug Conjugate in Ovarian & Endometrial Cancers

United States136 participantsStarted 2019-02-01

Plain-language summary

Phase 1 trial to study the safety, pharmacokinetics and preliminary efficacy of STRO-002 given intravenously every 3 weeks.

Who can participate

Age range18 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Age ≥ 18 years
✓. Measurable disease per RECIST 1.1
✓. ECOG performance status (0-1)
✓. Life expectancy \> 3 months
✓. Pathological confirmation of disease under study (historical information, diagnosis, pathology report, etc)
✓. Expansion Cohorts A and C: High-grade serous EOC, fallopian tube cancer or primary peritoneal cancer
✓. Expansion Cohort B: Histologically diagnosed epithelial endometrial cancer (endometrioid and serous adenocarcinomas; undifferentiated carcinoma; mixed epithelial carcinoma; or adenocarcinoma NOS)
✓. Relapsed and/or progressive disease

Exclusion criteria

✕. Low grade (grade 1) ovarian carcinoma, clear cell, mucinous and sarcomatous ovarian carcinomas (Cohort A).
✕. Endometrial carcinosarcomas, leiomyosarcoma and stromal sarcomas (Cohort B).
✕. Prior treatment with a FolRα-targeting ADCs or FolRα-targeting vaccines
✕. Platinum-refractory during frontline treatment (Cohorts A and C)
✕. Greater than 3 lines of prior treatment
✕. History of severe allergic or anaphylactic reactions to monoclonal antibody therapy or to antibody-related fusion protein treatment
✕. Preexisting clinically significant ocular disorders, clinically significant pre-exisiting ocular disorders, severe chronic obstructive pulmonary disease or asthma, clinically significant cardiac or cerebrovascular disease, or other significant concurrent, uncontrolled medical condition
✕. Metastatic central nervous system or meningeal disease

What they're measuring

Part 1: Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability of STRO-002)

Timeframe: 18 months

Part 1: Define the recommended phase 2 dose (RP2D) of STRO-002

Timeframe: 18 months

Part 1: Define the maximum tolerated dose (MTD) of STRO-002

Timeframe: 18 months

Part 2: Evaluate preliminary anti-tumor activity (ovarian, Fallopian and primary peritoneal cancer patients)

Timeframe: 24 months

Part 2: Evaluate preliminary anti-tumor activity (endometrial cancer patients)

Timeframe: 24 months

Trial details

NCT IDNCT03748186

SponsorSutro Biopharma, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-06-04

View on ClinicalTrials.gov More Ovarian Cancer trials

Who can participate

Age range18 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Age ≥ 18 years
✓. Measurable disease per RECIST 1.1
✓. ECOG performance status (0-1)
✓. Life expectancy \> 3 months
✓. Pathological confirmation of disease under study (historical information, diagnosis, pathology report, etc)
✓. Expansion Cohorts A and C: High-grade serous EOC, fallopian tube cancer or primary peritoneal cancer
✓. Expansion Cohort B: Histologically diagnosed epithelial endometrial cancer (endometrioid and serous adenocarcinomas; undifferentiated carcinoma; mixed epithelial carcinoma; or adenocarcinoma NOS)
✓. Relapsed and/or progressive disease

Exclusion criteria

✕. Low grade (grade 1) ovarian carcinoma, clear cell, mucinous and sarcomatous ovarian carcinomas (Cohort A).
✕. Endometrial carcinosarcomas, leiomyosarcoma and stromal sarcomas (Cohort B).
✕. Prior treatment with a FolRα-targeting ADCs or FolRα-targeting vaccines
✕. Platinum-refractory during frontline treatment (Cohorts A and C)
✕. Greater than 3 lines of prior treatment
✕. History of severe allergic or anaphylactic reactions to monoclonal antibody therapy or to antibody-related fusion protein treatment
✕. Preexisting clinically significant ocular disorders, clinically significant pre-exisiting ocular disorders, severe chronic obstructive pulmonary disease or asthma, clinically significant cardiac or cerebrovascular disease, or other significant concurrent, uncontrolled medical condition
✕. Metastatic central nervous system or meningeal disease

What they're measuring

Part 1: Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability of STRO-002)

Timeframe: 18 months

Part 1: Define the recommended phase 2 dose (RP2D) of STRO-002

Timeframe: 18 months

Part 1: Define the maximum tolerated dose (MTD) of STRO-002

Timeframe: 18 months

Part 2: Evaluate preliminary anti-tumor activity (ovarian, Fallopian and primary peritoneal cancer patients)

Timeframe: 24 months

Part 2: Evaluate preliminary anti-tumor activity (endometrial cancer patients)

Timeframe: 24 months