Disitamab Vedotin Plus Lenvatinib and PD-1 Inhibitors for Treating HER2-positive Advanced Biliary Tract Cancer

NCT07159217 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: K8721
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

Brief Summary

This trial is a single-arm exploratory phase II clinical study initiated by the investigator. Subjects who met the research criteria were screened and enrolled to receive the treatment regimen of disitamab vedotin combined with lenvatinib and PD-1 inhibitor. During the treatment process, the researchers closely followed up, strictly evaluated the efficacy, assessed the efficacy and safety of the subjects after receiving the combined treatment, evaluated the subjects until progression occurred, and observed their objective response rate, progression-free survival, overall survival, disease control rate, duration of response, and safety evaluation.

Conditions

Biliary Tract Cancer; Disitamab Vedotin; Lenvatinib; Immune Checkpoint Inhibitors

Keywords

Biliary tract cancer; Disitamab vedotin; Lenvatinib; Immune checkpoint inhibitors

Outcome Measures

Primary Outcomes (1)

• ORR, objective response rate

  12 months after the last subject is enrolled

Secondary Outcomes (5)

• PFS, progression free survival

  12 months after the last subject is enrolled

• OS, overall survival

  12 months after the last subject is enrolled

• DCR, disease control rate

  12 months after the last subject is enrolled

• DoR, duration of response

  12 months after the last subject is enrolled

• Adverse events (AE) and serious adverse events (SAE)

  12 months after the last subject is enrolled

Study Arms (1)

Disitamab vedotin combined with lenvatinib and PD-1 inhibitor

EXPERIMENTAL

Disitamab vedotin combined with lenvatinib and PD-1 inhibitor (Pembrolizumab or Toripalimab or Camrelizumab)

Drug: Disitamab Vedotin; Drug: Lenvatinib; Drug: Pembrolizumab; Drug: Toripalimab; Drug: Camrelizumab

Interventions

Disitamab Vedotin DRUG

2.0 mg/kg administered intravenously every three weeks

Disitamab vedotin combined with lenvatinib and PD-1 inhibitor

Lenvatinib DRUG

≥60 kg: 12 mg once daily, or \<60 kg: 8 mg once daily

Disitamab vedotin combined with lenvatinib and PD-1 inhibitor

Pembrolizumab DRUG

200 mg intravenously every three weeks

Disitamab vedotin combined with lenvatinib and PD-1 inhibitor

Toripalimab DRUG

240 mg intravenously every three weeks

Disitamab vedotin combined with lenvatinib and PD-1 inhibitor

Camrelizumab DRUG

200 mg intravenously every three weeks

Disitamab vedotin combined with lenvatinib and PD-1 inhibitor

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants who voluntarily participate in this study, sign the written informed consent, and are able to comply with the protocol.
• Age ≥ 18 years and any gender.
• Histologically or cytologically confirmed unresectable locally advanced or metastatic biliary tract cancer (BTC), including intrahepatic cholangiocarcinoma (ICC), extrahepatic cholangiocarcinoma (ECC), and gallbladder cancer (GBC).
• At least one measurable lesion (according to RECIST 1.1).
• ECOG performance status score of 0-1.
• Child-Pugh score ≤ 7 .
• HER2 expression confirmed by: Immunohistochemistry (IHC 2+ or 3+); or Fluorescence in situ hybridization (FISH) with HER2/CEP17 ratio ≥2.0; or Next-generation sequencing (NGS) showing HER2 amplification.
• No prior HER2-targeted therapy (including antibody-based agents, small-molecule TKIs, or antibody-drug conjugates) before randomization.
• Expected survival \> 12 weeks.
• Adequate hematological and major organ function.

You may not qualify if:

• Histological or cytological diagnosis of combined hepatocellular-cholangiocarcinoma (cHCC-CCA), mucinous adenocarcinoma, sarcoma, or neuroendocrine tumors.
• Pregnant women (positive pregnancy test before medication) or lactating women.
• Known allergy or intolerance to disitamab vedotin, lenvatinib, PD-1 inhibitors, or their excipients.
• History of other active malignancies within 5 years prior to screening.
• Presence of central nervous system metastasis and/or leptomeningeal metastasis.
• Unhealed severe wounds, active ulcers, or untreated fractures.
• Administration of live vaccines within 30 days prior to randomization.
• Active autoimmune disease or history of autoimmune disease.
• Presence of clinically significant gastrointestinal disorders.
• Presence of clinically significant cardiovascular or cerebrovascular diseases.

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Chinese Academy of Medical Sciences, Peking Union Medical College Hospital

Beijing, China

Location

Related Publications (1)

• Shi F, Liu Y, Zhou X, Shen P, Xue R, Zhang M. Disitamab vedotin: a novel antibody-drug conjugates for cancer therapy. Drug Deliv. 2022 Dec;29(1):1335-1344. doi: 10.1080/10717544.2022.2069883.

  PMID: 35506447 BACKGROUND

MeSH Terms

Conditions

Biliary Tract Neoplasms

Interventions

disitamab vedotin; lenvatinib; pembrolizumab; toripalimab; camrelizumab

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Biliary Tract Diseases; Digestive System Diseases

Central Study Contacts

Shuofeng Li

CONTACT

+86-10-69156042; shuofengli@yeah.net

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2025
• First Posted: September 8, 2025
• Study Start: August 30, 2025
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): May 31, 2028
• Last Updated: September 8, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)