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A Prospective Study of Sacituzumab Tirumotecan Plus Pembrolizumab for Advanced Biliary Tract Cancer

ConditionBiliary Tract Cancer (BTC)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorHaitao Zhao, MD

About this trial

The purpose of this study is to explore the effects of sacituzumab tirumotecan combined with pembrolizumab on survival, disease progression, and safety in patients with advanced biliary tract malignancies in the second-line and later settings. This is a multicenter, phase II, interventional single-arm clinical study. A total of 38 participants will be enrolled. Participants will receive the combination therapy until disease progression or unacceptable toxicity.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Subjects must voluntarily participate in the study, sign a written informed consent form (ICF), demonstrate good compliance, and cooperate with follow-up visits. Subjects must be $\ge$ 18 and < 75 years of age at the time of signing the ICF, with no gender restrictions.

Histologically and radiologically confirmed advanced biliary tract cancer (BTC) that is unresectable, recurrent, locally advanced, or metastatic, defined as Stage IIIA or higher according to the AJCC 8th edition staging system, including intrahepatic or extrahepatic cholangiocarcinoma and gallbladder cancer.

Disease progression after one or more prior lines of standard therapy.

Ineligible for radical surgery/local therapy for at least 4 weeks prior to baseline assessment, or experienced disease progression thereafter. The aforementioned treatments include lesion resection, ablation, transarterial chemoembolization (TACE), hepatic arterial infusion chemotherapy (HAIC), radiotherapy, etc. All acute toxicities from local therapy must have resolved to ≤ Grade 1 per CTCAE v5.0.

Disqualifiers

Prior treatment with TROP2-targeted therapy and/or topoisomerase I inhibitors.

Patients currently receiving approved or investigational systemic anti-cancer therapies, including chemotherapy, biological immunotherapy, targeted therapy, or traditional Chinese medicine with specific anti-cancer indications. (Such treatments are permitted if completed at least 4 weeks prior to enrollment).

Histopathological findings indicating mixed hepatocellular cholangiocarcinoma, the presence of squamous cell carcinoma or sarcomatoid components, or ampullary carcinoma.

Presence of other uncured malignancies within the past 5 years (excluding cured basal cell carcinoma of the skin and cervical carcinoma in situ).

Trial design

Design model

Single group

Treatments tested in this trial

  • Sacituzumab Tirumotecan (SKB264)

    Drug

    Sacituzumab tirumotecan will be administered at a dose of 4 mg/kg via intravenous infusion every 2 weeks. The treatment will continue until documented disease progression, occurrence of unacceptable toxicity, withdrawal of consent, or other protocol-specified criteria for discontinuation are met.

  • Pembrolizumab

    Drug

    Pembrolizumab will be administered at a fixed dose of 200 mg via intravenous infusion every 3 weeks. The treatment will continue until documented disease progression, occurrence of unacceptable toxicity, withdrawal of consent, or other protocol-specified criteria for discontinuation are met.

Treatment groups

38 Participants
are divided into 1 treatment group
Group A: sacituzumab tirumotecan combined with pembrolizumabExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Objective response rate

Proportion of participants with a best overall response of complete response (CR) or partial response (PR) according to RECIST version 1.1, as assessed by investigators. Tumor assessments will be performed approximately every 6 weeks during the first year, and every 8-12 weeks thereafter.

Time frame
From the date of first study drug administration until the date of first documented disease progression or date of death from any cause, whichever came first, assessed up to approximately 12 months.

Secondary outcomes

1

Disease control rate

Proportion of participants with a best overall response of complete response (CR), partial response (PR), or stable disease (SD) according to RECIST version 1.1, as assessed by investigators. Tumor assessments will be performed approximately every 6 weeks during the first year, and every 8-12 weeks thereafter.

Time frame
From the date of first study drug administration until the date of first documented disease progression or date of death from any cause, whichever came first, assessed up to approximately 12 months.
2

Progression-Free Survival

Progression-Free Survival is defined as the time from the date of first study drug administration to the first occurrence of disease progression according to RECIST version 1.1, as assessed by investigators, or death from any cause.

Time frame
From the date of first study drug administration until the date of first documented disease progression or date of death from any cause, whichever came first, assessed up to approximately 24 months.
3

Overall Survival

Overall survival is defined as the time from the date of first study drug administration to death from any cause.

Time frame
From the date of first study drug administration until the date of death from any cause or the date of last valid follow-up, whichever came first, assessed up to approximately 24 months.
4

Duration of Response

Duration of response is defined as the time from the date of the first documented CR or PR to the date of the first documented disease progression according to RECIST version 1.1 or death from any cause.

Time frame
From the date of first documented CR or PR until the date of first documented disease progression or date of death from any cause, whichever came first, assessed up to approximately 24 months.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Haitao Zhao, MD

Lead sponsor

Peking Union Medical College Hospital

Sponsor institution

Source ClinicalTrials.gov
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