Trastuzumab Rezetecan Plus Bevacizumab in Platinum-Sensitive Recurrent Ovarian Cancer
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18-75
SponsorPeking University Cancer Hospital & Institute
About this trial
This study is a prospective, multicenter, single-arm, open-label phase II clinical trial.
It is planned to enroll 53 subjects with HER2-expressing (IHC 1+, 2+, or 3+) partially platinum-sensitive recurrent epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer (defined as disease recurrence occurring ≥6 months and \<12 months after the completion of the last platinum-containing therapy).
The study adopts a two-stage sequential treatment strategy:
Stage 1: All enrolled subjects will receive Trastuzumab Rezetecan (4.8 mg/kg IV, Q3W) combined with Bevacizumab (7.5 mg/kg IV, Q3W). Trastuzumab Rezetecan will be administered for a maximum of 1 year, or until disease progression, unacceptable toxicity, or other protocol-defined discontinuation criteria are met, whichever occurs first; Bevacizumab will be continued until disease progression, unacceptable toxicity, or other protocol-defined reasons.
Stage 2: Upon confirmed disease progression in Stage 1, subjects will enter Stage 2 to receive platinum-based chemotherapy (e.g., Carboplatin + Paclitaxel, Carboplatin + Liposomal Doxorubicin, or Carboplatin + Gemcitabine ± Bevacizumab; Cisplatin or Nedaplatin may replace Carboplatin in cases of intolerance, including but not limited to these regimens, determined by the investigator) until subsequent disease progression or unacceptable toxicity.
The primary objective is to evaluate progression-free survival 1 (PFS1) of SHR-A1811 combined with bevacizumab based on RECIST v1.1. Secondary objectives include objective response rate (ORR), disease control rate (DCR), progression-free survival 2 (PFS2), overall survival (OS), and safety and tolerability.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Voluntarily agree to participate in the study, provide written informed consent, demonstrate good compliance, and be able to cooperate with protocol-required follow-up visits.
Female patients aged 18 to 75 years old (inclusive, calculated from the date of signing the informed consent form).
Histologically or cytologically confirmed epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer (mucinous carcinoma is excluded).
Received 1 to 2 prior lines of systemic therapy and must have received prior PARP inhibitor therapy.
Disqualifiers
Central nervous system (CNS) metastasis: Untreated or active CNS metastases. Subjects are eligible if CNS metastases have received adequate local therapy (e.g., surgery or radiotherapy), neurological symptoms have returned to baseline (excluding residual signs or symptoms related to CNS treatment), and clinical stability has been maintained for ≥ 4 weeks prior to the first dose.
Second primary malignancy, except for the following: adequately treated basal cell carcinoma of the skin, cervical carcinoma in situ, ductal carcinoma in situ of the breast, or papillary thyroid carcinoma; or other malignancies that have been adequately treated with curative intent and have shown no evidence of recurrence or metastasis for >= 2 years prior to the first dose.
Uncontrolled pleural effusion or ascites. Subjects are eligible if therapeutic drainage has been performed and clinical stability has been maintained for at least 2 weeks after drainage.
Severe pulmonary disease: History of interstitial lung disease (ILD) or non-infectious pneumonitis (such as radiation pneumonitis) requiring systemic corticosteroid therapy; current or suspected ILD, non-infectious pneumonitis, or other active pulmonary inflammation; or significant pulmonary impairment including severe asthma, severe chronic obstructive pulmonary disease (COPD), or restrictive lung disease within 6 months prior to the first dose.
Trial design
Design model
Single group
Treatments tested in this trial
Trastuzumab Rezetecan (SHR-A1811)
DrugHumanized anti-HER2 IgG1 monoclonal antibody conjugated with a topoisomerase I inhibitor payload (SHR169265). Administered IV at 4.8 mg/kg on Day 1 of each 21-day cycle.
Bevacizumab
DrugRecombinant humanized anti-VEGF monoclonal antibody. Administered IV at 7.5 mg/kg on Day 1 of each 21-day cycle (dosing interval \>30 min after SHR-A1811).
Platinum-based chemotherapy
DrugPlatinum-based chemotherapy rechallenge administered in Stage 2, selected by the investigator based on patient clinical condition (including but not limited to: Carboplatin + Paclitaxel ± Bevacizumab, Carboplatin + Pegylated Liposomal Doxorubicin ± Bevacizumab, or Carboplatin + Gemcitabine ± Bevacizumab; Cisplatin or Nedaplatin may be substituted if carboplatin is not tolerated).
Treatment groups
53 Participants
are divided into 1 treatment groupGroup A: Sequential Treatment GroupExperimental treatment 3 interventions
Trial outcomes
Primary outcomes
1
PFS1
Progression-Free Survival 1 (PFS1) as assessed by the investigator based on Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1). Defined as the time from the date of the first dose of study treatment to the date of first documented objective tumor progression or death due to any cause, whichever occurs first.
Time frame
From the first dose of study treatment up to approximately 36 months.Secondary outcomes
1
Objective Response Rate (ORR)
Defined as the proportion of subjects who achieve a Best Overall Response (BOR) of confirmed Complete Response (CR) or Partial Response (PR) based on RECIST v1.1 criteria.
Time frame
Up to approximately 36 months.2
Disease Control Rate (DCR)
Defined as the proportion of subjects who achieve Complete Response (CR), Partial Response (PR), or Stable Disease (SD) based on RECIST v1.1 criteria.
Time frame
Up to approximately 36 months.3
Progression-Free Survival 2 (PFS2)
Defined as the time from the date of the first dose of study treatment in Stage 1 to the second documented objective disease progression or death due to any cause, whichever occurs first.
Time frame
Up to approximately 36 months.4
Overall Survival (OS)
Defined as the time from the date of the first dose of study treatment to death due to any cause, calculated in the intent-to-treat (ITT) population.
Time frame
Up to approximately 36 months.Sponsors and contacts
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Source ClinicalTrials.gov
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