A basket study to investigate the efficacy and safety of SKB264 in combination with pembrolizumab in subjects with solid tumors

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Sichuan Kelun-Biotech Biopharmaceutical Co. Ltd.

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

11 Sep 2023 → ongoing

Decision date (initial)

2023-06-13

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd, Chengdu, China.

External identifiers

EU CT number

2022-502654-14-00

ClinicalTrials.gov

NCT05642780

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Others, Efficacy, Pharmacokinetic

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

Secondary objectives 3

1. To assess the safety and efficacy of SKB264 in combination with pembrolizumab.
2. To assess how the body absorbs, transports, breaks down and removes the study drug(SKB264) [this is called Pharmacokinetics (PK)].
3. To assess the effects of SKB264 in combination with pembrolizumab on immune (defense) system.

Conditions and MedDRA coding

Endometrial cancer

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 1

1. 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).

Exclusion criteria 4

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

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

1. The primary study endpoints of safety are the number of subjects with dose-limiting toxicities (side effects due to the study drug), number of subjects with adverse events (any side effects related or unrelated to the study drug) and number of subjects discontinuing the study drug due to adverse events.
2. The primary study endpoints of efficacy are the proportion of subjects with a confirmed complete response or partial response and the percentage of subjects who have a negative change (decrease) in prostate-specific antigen level (a type of protein produced by prostate gland in men).

Secondary endpoints 7

1. Vital signs, physical examination, laboratory tests, 12-lead electrocardiogram/ echocardiogram/multiple-gated acquisition scan (MUGA), and eastern cooperative oncology group performance status. These tests will be done to assess the safety of SKB264 in combination with pembrolizumab.
2. The disease control rate, duration of response, progressionfree survival, and overall survival. These are the tests to assess the antitumor activity (preventing or inhibiting the formation or growth of tumors) of SKB264 in combination with pembrolizumab
3. Area under the serum concentration curve (AUC): AUC shows how much drug has entered the blood over a period of time.
4. Minimum serum concentration (Cmin): Cmin is the least amount of drug that remains in blood after one dose is given.
5. Maximum serum concentration (Cmax): Cmax shows the most amount of drug found in blood after one dose is given.
6. Test for presence of antibodies against the study drug. Number of subjects with positive anti-drug antibodies (ADA) test.
7. ADA titers (concentration of ADA in blood)

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

Auxiliary 4

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Sichuan Kelun-Biotech Biopharmaceutical Co. Ltd.

Sponsor organisation

Sichuan Kelun-Biotech Biopharmaceutical Co. Ltd.

Address

No. 666 Xinhuaavenue, Chengduhaixialiangantechnologyindustrydevelopmentpark Chengduhaixialiangantechnologyindustrydevelopmentpark

Postcode

610072

Country

China

Scientific contact point

Organisation

Sichuan Kelun-Biotech Biopharmaceutical Co. Ltd.

Contact name

Chief Medical Officer

Public contact point

Organisation

Sichuan Kelun-Biotech Biopharmaceutical Co. Ltd.

Contact name

Medical Monitor

Third parties 8

Locations

4 EU/EEA countries · 21 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Oversight and notifications

Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77

Unexpected events 1 · Art. 53 CTR

Note: SUSARs are reported via EudraVigilance, not CTIS — events shown here are CTIS-public notifications only.

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 51 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

13 submissions — initial application plus substantial / non-substantial modifications