A Study of AK112 Monotherapy in Advanced/Metastatic Renal Cell Carcinoma

NCT06472895 | Not Yet Recruiting Phase 1

• 1 other identifier: AK112-001-II-RCC
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is an open-label, single arm , Ib/II phase trial to evaluate the efficacy and safety of AK112（ivonescimab）monotherapy as first-line treatment for favourable risk advanced/metastatic renal cell carcinoma (a/m RCC). Subjects will receive AK112 until disease progression, unacceptable toxic effects, death，a decision by the physician or patient to withdraw from the trial，or AK112 exposure over 2 years. The study set dose exploration stage and dose expansion stage respectively. Firstly, include a few subjects for observation in dose exploration stage, and select appropriate dose to enter expansion, then continue to include more subjects to further assessment.

Conditions

Renal Cell Carcinoma

Keywords

RCC，immunotherapy，AK112，first-line treatment

Outcome Measures

Primary Outcomes (1)

• ORR per RECIST v1.1 assessed by investigators

  ORR is the proportion of subjects with complete response(CR) and partial response(PR) , based on RECIST v1.1

  Up to 2 years

Secondary Outcomes (5)

• DCR per RECIST v1.1 as assessed by investigators

  Up to 2 years

• Duration of response (DOR)

  Up to 2 years

• Progression-free survival (PFS)

  3 years

• Overall survival (OS)

  4 years

• Treatment-related adverse events

  3 years

Study Arms (1)

treatment group

EXPERIMENTAL

Subjects will receive AK112 (RP2D, administered intravenously，Q3W)

Drug: AK112 monotherapy

Interventions

AK112 monotherapy DRUG

A novel PD-1/VEGF bispecific antibody; RP2D intravenously (IV)，Q3W

treatment group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provide written informed consent/assent for the trial.
• Be ≥18 and ≤ 75 years of age on day of signing informed consent, no matter male or female.
• IMDC favourable risk（IMDC score 0）.
• ECOG PS 0-1.
• Have estimated life expectancy of at least 3 months.
• Have histologically or cytologically confirmed diagnosis of RCC with mainly clear cell carcinoma component.
• Have received no prior systemic therapy for advanced RCC，Including but not limited to Immunotherapy, target therapy, chemotherapy, biological therapy, etc.
• Note: Prior neoadjuvant/adjuvant therapies are acceptable if disease progression occurred \> 6 months after last dosage of neoadjuvant/adjuvant treatment.
• Have measurable disease per RECIST v1.1 .
• Adequate organ function.
• Contraception from entering the trial，until 120 days after the last administration of the investigational drug.
• Willing to comply with the scheduled visits, treatment plans, and other requirements of the trial.

You may not qualify if:

• non-clear cell renal cell carcinoma，nccRCC（e.g. chromophobe, papillary)
• Has active autoimmune disease that might deteriorate when receiving an immunostimulatory agents. Subjects with diabetes type I, vitiligo, psoriasis, hypo-or hyperthyroid disease not requiring immunosuppressive treatment are eligible.
• Has a known additional malignancy that has progressed or has required active treatment in the last 5 years.
• Note: Subjects with basal cell carcinoma of the skin, squamous cell carcinoma of the skin that has undergone potentially curative therapy or carcinoma in situ are not excluded.
• Eligible for surgery.
• History of severe bleeding or coagulation disorders.
• History of abdominal fistula or gastrointestinal perforation related to anti VEGF therapy.
• Has previously received systemic therapy.
• Has newly diagnosed brain metastases or known symptomatic brain metastases requiring steroids.
• Had major surgery 4 weeks prior to receiving first dose of trial treatment.
• Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 14 days prior to receiving first dose of trial treatment.
• Has an active tuberculosis and syphilitic infection.
• Has a known history of Human Immunodeficiency Virus (HIV) infection (HIV antibodies).
• Has known active Hepatitis B (e.g., Hepatitis B surface antigen \[HBsAg\] reactive and HBV-DNA\>2000 IU/ml) or Hepatitis C virus (e.g., HCV RNA \[qualitative\] is detected).
• Has been pregnant or breastfeeding.

Sponsors & Collaborators

• Peking University Cancer Hospital & Institute: lead

MeSH Terms

Conditions

Carcinoma, Renal Cell

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Central Study Contacts

Xinan Sheng, MD

CONTACT

+86-10-88196348; doctor_sheng@126.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: June 19, 2024
• First Posted: June 25, 2024
• Study Start: July 20, 2024
• Primary Completion: December 20, 2025
• Study Completion (Estimated): December 20, 2027
• Last Updated: June 25, 2024

Record last verified: 2024-06