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Taking peoplePhase 2

Tests SKB264 with pembrolizumab in several solid tumor types

Tests SKB264 with pembrolizumab in adults with selected solid tumors.

Key facts

Who runs it
Sichuan Kelun-Biotech Biopharmaceutical Co. Ltd.
Where
Bordeaux, Caen Cedex 5, Clermont-Ferrand, Dijon, Marseille, Paris, Pierre-Bénite, and Poitiers, FranceSee the 8 sitesAlso in 3 other countries, 13 sites
Registry title
A basket study to investigate the efficacy and safety of SKB264 in combination with pembrolizumab in subjects with solid tumors
Status
Recruiting
Phase
Phase 2
People taking part
101 people, planned
Started
11 Sept 2023
Expected to end
4 Feb 2027
Type of study
Interventional, 5 groups
Record updated
19 May 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with advanced, spreading or recurrent cervical, urothelial, ovarian, prostate or endometrial cancer, confirmed by tissue or cell tests.

Age
18 years and older
Sex
Men and women can join.
Disease stage
Locally advanced, metastatic or recurrent cancer of the cervix, urothelium, ovary, prostate or endometrium, confirmed by tissue or cell tests.
Earlier treatment
People cannot join if they had chemotherapy, radiotherapy, immunotherapy or biologic therapy within 4 weeks before the first dose of the study drug.

Main reasons for not taking part

  • Active tumors or spread of cancer in the central nervous system
  • Hepatitis B, hepatitis C, HIV or active tuberculosis
  • Past allogeneic tissue or solid organ transplant
  • Chemotherapy, radiotherapy, immunotherapy or biologic therapy within 4 weeks before the first dose

The registry criteria, word for word

Show all 5 criteriaShow less

Who can take part

  • Male and/or females of age 18 years and older who have histologically or cytologically confirmed locally advanced or metastatic cancer or recurrent cancer (Cervical, Urothelial, Ovarian, Prostate or Endometrial cancer)

Who cannot take part

  • Subjects who received any chemotherapy, radiotherapy, immunotherapy, or biologic therapy treatment within 4 weeks before the first dose of the study drug
  • Subjects with hepatitis B, hepatitis C, human immunodeficiency virus (HIV) or active Tuberculosis
  • Subjects with a history of allogeneic tissue or solid organ transplant
  • Subjects with active central nervous system tumors or metastases

Where in France

Also in 3 other countries, 13 sites

  • Institut BergonieBordeaux, FranceNo longer taking part
  • Centre Francois BaclesseCaen Cedex 5, FranceNo longer taking part
  • Centre Jean PerrinClermont-Ferrand, FranceNo longer taking part
  • Centr Georges Francois LeclercDijon, FranceNo longer taking part
  • Institut Paoli-CalmettesMarseille, FranceNo longer taking part
  • Assistance Publique Hopitaux de ParisParis, FranceNo longer taking part
  • Centre Hospitalier Lyon-SudPierre-Bénite, FranceNo longer taking part
  • Centre Hospitalier Universitaire de PoitiersPoitiers, FranceNo longer taking part

About the trial

What the trial wants to find out

The main purpose of this study is to see if SKB264 in combination with pembrolizumab is safe and effective in treating selected solid tumors.

The 5 groups in the trial

  • cohort ATreatment being tested

    subjects will receive SKB264 in combination with pembrolizumab by intravenous administration

    Treatment: SKB264 and Pembrolizumab

  • cohort BTreatment being tested

    subjects will receive SKB264 in combination with pembrolizumab by intravenous administration

    Treatment: SKB264 and Pembrolizumab

  • cohort CTreatment being tested

    subjects will receive SKB264 in combination with pembrolizumab by intravenous administration

    Treatment: SKB264 and Pembrolizumab

  • cohort DTreatment being tested

    subjects will receive SKB264 in combination with pembrolizumab by intravenous administration

    Treatment: SKB264 and Pembrolizumab

  • Cohort ETreatment being tested

    subjects will receive SKB264 in combination with pembrolizumab by intravenous administration

    Treatment: SKB264 and Pembrolizumab

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
Official title
A multicenter, open-label, phase 2, basket study to evaluate the efficacy and safety of SKB264 in combination with pembrolizumab in subjects with selected solid tumors
Plain-language title
Tests SKB264 with pembrolizumab in several solid tumor typesGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 9 November 2026.
Record updated
19 May 2026