Clinical trial · Interventional

A Study of SHR-A1921 With or Without Carboplatin in Subjects With Ovarian Cancer

An Open-label, Randomized, Controlled, Phase II/III Study of SHR-A1921 With or Without Carboplatin Verus Investigator's Choice of Platinum-based Doublet Chemotherapy in Patients With Recurrent Epithelial Ovarian Cancer

NCT06211023CI-TRIAL-00073111unknownPhase 2 / Phase 3ClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

This is an open-label, randomized, controlled, two-part study to evaluate the safety and efficacy of SHR-A1921 with or without carboplatin verus investigator's choice of platinum-based doublet chemotherapy in subjects with recurrent epithelial ovarian cancer.

Conditions

Conditions (1)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Ovarian Cancer	Malignant Ovarian Neoplasm	CURATED_EXACT	0.92

Interventions

Interventions (3)

Intervention	Type	Mapped drug	Match
carboplatin	Drug	Carboplatin	ALIAS
platinum-based doublet chemotherapy	Drug	—	UNRESOLVED
SHR-1921	Drug	—	UNRESOLVED

Design

Arms and outcomes

Arms (4)

type
EXPERIMENTAL
label
Treatment group 1: SHR-1921
interventionNames
1. Drug: SHR-1921
type
EXPERIMENTAL
label
Treatment group 2: SHR-1921 + carboplatin dose level 1
interventionNames
1. Drug: carboplatin
type
EXPERIMENTAL
label
Treatment group 3: SHR-1921 + carboplatin dose level 2
interventionNames
1. Drug: carboplatin
type
OTHER
label

Eligibility

Eligibility (as posted)

Sex: Female
Minimum age: 18 Years

Show eligibility criteria text

Inclusion Criteria:

1. Voluntary participation and written informed consent.
2. Be able to provide fresh or archived tumour tissue.
3. Pathologically diagnosed epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer.
4. At least one measurable lesion according to RECIST v1.1.
5. Eastern Cooperative Oncology Group (ECOG) score: 0-1.
6. With a life expectancy ≥ 12 weeks.
7. Adequate bone marrow reserve and organ function.

Exclusion Criteria:

1. Uncontrolled pleural effusion, pericardial effusion, or abdominal effusion with clinical symptoms.
2. Previous or co-existing malignancies.
3. Has a history of non-infectious ILD/pneumonitis that required steroids, or has current ILD/pneumonitis;
4. Subjects with active hepatitis B or active hepatitis C;
5. Subjects who have received systemic anti-tumor treatments 4 weeks prior to the initiation of the study treatment.
6. Subjects who have been treated with TOP1 inhibitors, TROP-2 ADC or ADCs with TOP1 inhibitors as payload.
7. Has unresolved CTCAE ≥grade 2 toxicities from previous anticancer therapy.

References

Publications (0)

Data not yet available

No reference posted for this study.