A Phase II Clinical Study Evaluating The Efficacy and Safety of KN046 in Combination With Regorafenib or Apatinib for Microsatellite Instability-High Digestive System Cancers Resistant to PD-1/PD-L1 Blockade

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

The study is an interventional phase II clinical trial aiming to evaluate the efficacy and safety of KN046, a PD-L1 and CTLA-4 bispecific antibody, in combination with regorafenib or apatinib for microsatellite instability-high digestive system cancers resistant to PD-1/PD-L1 blockade. KN046 plus regorafenib will be given for patients with colorectal cancers, and KN046 plus apatinib will be given for patients with gastric cancers (including esophageal-gastric junction cancers) and other kinds of digestive system cancers.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
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• Subjects are able to comprehend the informed consent form, voluntarily participate, and sign the informed consent form.

• Subjects are ≥18 years old on the day of signing the informed consent form, with no gender restrictions.

• Histologically confirmed digestive system cancers.

• According to RECIST 1.1 criteria, there should be at least one measurable or evaluable lesion at baseline. If the subject has only one measurable or evaluable lesion at baseline, the lesion must not have been exposed to radiotherapy previously, or there must be evidence of significant progression after radiotherapy treatment completion.

• ECOG performance status of 0 or 1.

• Expected survival ≥3 months.

• Archived tumor tissue samples or freshly obtained tumor tissue samples are available.

• Female subjects of childbearing potential or male subjects with partners of childbearing potential agree to use highly effective contraception from 7 days before the first dose until 120 days after the last dose. Female subjects of childbearing potential must have a negative serum pregnancy test within 7 days before the first dose.

• Subjects have the ability and willingness to comply with the study protocol's visits, treatment plan, laboratory tests, and other study-related procedures.

• Within the first 7 days of initial dosing, subjects should have good organ function:

• HGB ≥ 80g/L, NEU ≥ 1.0\*10\^9/L, PLT ≥ 75\*10\^9/L, Cr≤1.5×ULN or CrCl≥50mL/min(Cockcroft-Gault method), TBiL ≤ 1.5×ULN, ALT and AST ≤3 ×ULN; for patients with liver metastasis ALT and AST ≤5 ×ULN, urine protein \<2+;,if urine protein ≥ 2+, 24 hour urinary protein quantity \<2g; INR, APTT, PT ≤ 1.5 ×ULN

• dMMR/MSI-H cancers resistant to PD1/PDL1 blockade. MSI status should be confirmed by PCR or NGS. If MSI status by PCR and NGS were not consistent, or no enough tissue were available for PCR or NGS testing, whether to enroll this patient should be determine by investigators.

Locations
Other Locations
China
Peking University Cancer Hospital
RECRUITING
Beijing
Contact Information
Primary
Zhenghang Wang
zhenghang_wang@bjmu.edu.cn
01088196561
Backup
Ting Xu
xtlmhxt@163.com
18201137836
Time Frame
Start Date: 2023-10-25
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 39
Treatments
Experimental: Patients resistant to PD1/PDL1 blockade
Patients with microsatellite instability-high digestive system cancers resistant to PD-1/PD-L1 blockade
Related Therapeutic Areas
Sponsors
Leads: Peking University Cancer Hospital & Institute

This content was sourced from clinicaltrials.gov