OncoMatch/Clinical Trials/NCT06834672
Study of IBI354 Versus Investigator's Choice of Chemotherapy in Patients With Platinum-resistant Ovarian, Primary Peritoneal, or Fallopian Tube Cancer
Is NCT06834672 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments including IBI354 and paclitaxel/Gemcitabine/Liposomal doxorubicin for ovarian.
Treatment: IBI354 · paclitaxel/Gemcitabine/Liposomal doxorubicin — This is a multiregional, multicenter, randomized, open-label, phase III study to compare the efficacy, safety, and tolerability of IBI354 monotherapy with investigator's choice of chemotherapy (paclitaxel, gemcitabine, liposomal doxorubicin, or topotecan) in patients with HER2-expressing, platinum-resistant ovarian, primary peritoneal, or fallopian tube cancer. Participants with advanced ovarian, primary peritoneal, fallopian tube cancer who have failed or are intolerant to first-line or more platinum-based chemotherapy will be randomly assigned in a 2:1 ratio to two treatment arms: Experimental Arm: IBI354 monotherapy arm, 12 mg/kg IBI354 on Day 1 of each 3-week cycle; Control Arm: Investigator's choice chemotherapy (paclitaxel, gemcitabine, liposomal doxorubicin, or topotecan)
Check if I qualifyExtracted eligibility criteria
Cancer type
Ovarian Cancer
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: any anticancer therapy
Must have confirmed disease progression during or after the most recent anticancer therapy.
Cannot have received: paclitaxel (paclitaxel)
Exception: ineligible or had previously received and progressed
Paclitaxel, gemcitabine, liposomal doxorubicin, and topotecan listed in the control arm were either ineligible or had previously received and progressed.
Cannot have received: gemcitabine (gemcitabine)
Exception: ineligible or had previously received and progressed
Paclitaxel, gemcitabine, liposomal doxorubicin, and topotecan listed in the control arm were either ineligible or had previously received and progressed.
Cannot have received: liposomal doxorubicin (liposomal doxorubicin)
Exception: ineligible or had previously received and progressed
Paclitaxel, gemcitabine, liposomal doxorubicin, and topotecan listed in the control arm were either ineligible or had previously received and progressed.
Cannot have received: topotecan (topotecan)
Exception: ineligible or had previously received and progressed
Paclitaxel, gemcitabine, liposomal doxorubicin, and topotecan listed in the control arm were either ineligible or had previously received and progressed.
Cannot have received: chemotherapeutic drugs (IV)
Participants who have been treated with Intravenous infusion of chemotherapeutic drugs, macromolecular targeted drugs, immunotherapy, intraperitoneal chemotherapy, tumor embolization or interventional chemotherapy, within 4 weeks.
Cannot have received: macromolecular targeted drugs
Participants who have been treated with Intravenous infusion of chemotherapeutic drugs, macromolecular targeted drugs, immunotherapy, intraperitoneal chemotherapy, tumor embolization or interventional chemotherapy, within 4 weeks.
Cannot have received: immunotherapy
Participants who have been treated with Intravenous infusion of chemotherapeutic drugs, macromolecular targeted drugs, immunotherapy, intraperitoneal chemotherapy, tumor embolization or interventional chemotherapy, within 4 weeks.
Cannot have received: intraperitoneal chemotherapy
Participants who have been treated with Intravenous infusion of chemotherapeutic drugs, macromolecular targeted drugs, immunotherapy, intraperitoneal chemotherapy, tumor embolization or interventional chemotherapy, within 4 weeks.
Cannot have received: tumor embolization or interventional chemotherapy
Participants who have been treated with Intravenous infusion of chemotherapeutic drugs, macromolecular targeted drugs, immunotherapy, intraperitoneal chemotherapy, tumor embolization or interventional chemotherapy, within 4 weeks.
Cannot have received: oral chemotherapeutic drugs
Participants who have been treated with oral chemotherapeutic drugs, small molecular targeted drugs, endocrine therapy, and Chinese herbal medicine for anticancer treatment indications, within 2 weeks or 5 half-lives (whichever is longer).
Cannot have received: small molecular targeted drugs
Participants who have been treated with oral chemotherapeutic drugs, small molecular targeted drugs, endocrine therapy, and Chinese herbal medicine for anticancer treatment indications, within 2 weeks or 5 half-lives (whichever is longer).
Cannot have received: endocrine therapy
Participants who have been treated with oral chemotherapeutic drugs, small molecular targeted drugs, endocrine therapy, and Chinese herbal medicine for anticancer treatment indications, within 2 weeks or 5 half-lives (whichever is longer).
Cannot have received: Chinese herbal medicine for anticancer treatment indications
Participants who have been treated with oral chemotherapeutic drugs, small molecular targeted drugs, endocrine therapy, and Chinese herbal medicine for anticancer treatment indications, within 2 weeks or 5 half-lives (whichever is longer).
Cannot have received: radical radiotherapy
Participants who have been treated with radical radiotherapy within 4 weeks, palliative radiotherapy within 2 weeks.
Cannot have received: palliative radiotherapy
Participants who have been treated with radical radiotherapy within 4 weeks, palliative radiotherapy within 2 weeks.
Cannot have received: strong cytochrome P450 3A4 (CYP3A4) inhibitors or inducers
Participants who have been treated with strong cytochrome P450 3A4 (CYP3A4) inhibitors or inducers within 2 weeks or 5 half-lives (whichever is longer).
Cannot have received: major surgery
Participants who have been treated with Major surgery (craniotomy, thoracotomy or laparotomy and other types of surgery considered "major" by the investigator, excluding needle biopsy) within 4 weeks; Laparoscopic exploration surgery within 2 weeks. Or participants have serious non-healing wound, trauma or ulcer.
Cannot have received: laparoscopic exploration surgery
Participants who have been treated with Major surgery (craniotomy, thoracotomy or laparotomy and other types of surgery considered "major" by the investigator, excluding needle biopsy) within 4 weeks; Laparoscopic exploration surgery within 2 weeks. Or participants have serious non-healing wound, trauma or ulcer.
Cannot have received: live vaccines
Exception: mRNA and non-replicating adenovirus vaccines are not considered live vaccines
Participants who have been treated with live vaccines (mRNA and non-replicating adenovirus vaccines are not considered live vaccines) within 4 weeks.
Lab requirements
Blood counts
Kidney function
Liver function
Cardiac function
Left Ventricular Ejection Fraction (LVEF) ≥ 50% within 28 days prior to the first dose of study drug.
Adequate bone marrow and organ function. Left Ventricular Ejection Fraction (LVEF) ≥ 50% within 28 days prior to the first dose of study drug.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify