Ivonescimab for Adrenocortical Carcinoma

No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if ivonescimab, a potential new drug, can help manage adrenocortical carcinoma (ACC) or pheochromocytoma and paraganglioma (PPGL) that have spread or recurred after other treatments. The study will assess how effectively this treatment controls these cancers. This trial may suit individuals with confirmed ACC or PPGL that has progressed and is not suitable for surgery. As a Phase 2 trial, the research focuses on evaluating the treatment's effectiveness in an initial, smaller group of participants.

Is there any evidence suggesting that ivonescimab is likely to be safe for humans?

Research has shown that ivonescimab generally has a manageable safety profile. In previous studies, about 14.6% of patients experienced serious side effects, known as Grade 3–4 adverse events, including low white blood cell counts and lung inflammation. However, these effects are similar to those expected from other treatments and can usually be managed.

Ivonescimab has undergone testing in other global trials, demonstrating a good balance between its tumor-fighting ability and its manageable safety profile. While some risks exist, most patients can tolerate the treatment well.12345

Why do researchers think this study treatment might be promising for ACC?

Ivonescimab is unique because it represents a novel approach to treating adrenocortical carcinoma (ACC) by specifically targeting cancer cells. While most standard treatments for ACC, like mitotane or chemotherapy, rely on broadly attacking rapidly dividing cells, ivonescimab works by harnessing and enhancing the body's own immune system to fight cancer more precisely. Researchers are particularly excited about its potential to reduce side effects and improve outcomes by focusing the treatment on the tumor cells while sparing healthy ones. This targeted action could lead to more effective and personalized treatment options for patients with ACC.

What evidence suggests that ivonescimab might be an effective treatment for ACC or PPGL?

Research has shown that ivonescimab yields promising results for cancer patients. In studies on non-small cell lung cancer, ivonescimab treatments significantly improved the disease control rate (DCR) compared to traditional chemotherapy. Specifically, patients receiving ivonescimab lived longer on average, with a survival time of 27.9 months compared to 23.7 months for those in the control group. The treatment also extended the period during which the cancer did not worsen. This trial will evaluate ivonescimab for adrenocortical carcinoma (ACC), and these findings suggest that ivonescimab could effectively manage advanced cancers like ACC.16789

Who Is on the Research Team?

MC

Matthew Campbell, MD

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

This trial is for adults with advanced or inoperable adrenal gland cancers (ACC or PPGL) that have already been treated but keep growing. Participants must be generally healthy aside from their cancer and able to attend study visits.

Inclusion Criteria

Unsterilized male participants having sex with female partner of childbearing potential or pregnant/breastfeeding partner must use barrier contraception during treatment and 90 days after last dose; female partner must use highly effective contraception
I have confirmed ACC or PPGL, with a high Weiss Score or large/invasive adrenal tumor.
My cancer is advanced or has spread and cannot be removed by surgery.
See 11 more

Exclusion Criteria

I have not had recent radiation or ongoing problems from previous radiation treatment.
I have not needed ongoing treatment for autoimmune or lung disease in the past 2 years.
Receipt of any other investigational agent within 28 days before first dose
See 28 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Ivonescimab intravenously every 3 weeks

1 year

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Ivonescimab

Trial Overview

The study is testing ivonescimab, a new medication, to see if it can help control ACC or PPGL tumors that can't be removed by surgery. All participants will receive this drug through an IV infusion.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: Cohort 2Experimental Treatment1 Intervention
Group II: Cohort 1Experimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials
3,107
Recruited
1,813,000+

Summit Therapeutics

Industry Sponsor

Trials
18
Recruited
4,500+

Citations

Efficacy and safety of ivonescimab in non-small cell lung cancer

Analysis of RCT data indicated that AK112-based regimens significantly improved DCR compared to conventional chemotherapy (OR = 2.29, 95% CI: 1.18–4.44; Figure ...

Efficacy of Ivonescimab Plus Chemo May Vary Across ...

The median OS was 16.8 months in the ivonescimab arm and 14.0 months in the control arm (HR, 0.79; 95% CI, 0.62-1.01; P =.0570). Among patients ...

Akeso, Inc | Ivonescimab Receives NMPA Approval for First ...

Ivonescimab demonstrated a statistically significant improvement in the trial's primary end point, median progression-free survival (PFS)

NCT07743138 | STOMP OUT: A Phase 2 Study To ...

Study Overview. Brief Summary. To learn if ivonescimab can help to control previously treated, locally advanced or metastatic ACC or PPGL.

📊 Research Summary: Ivonescimab plus chemotherapy ...

Ivonescimab significantly improved the objective response rate (50.0% vs. 38.5%) and disease control rate (89.9% vs. 70.5%) for PD-L1 positive ...

Safety, Pharmacokinetics, and Pharmacodynamics Evaluation ...

As of data cutoff on July 30, 2023, the median follow‐up was 24.1 months (range: 1.7–30.3 months). Ivonescimab treatment was still ongoing for one of 6 patients ...

Encouraging Global Phase II Ivonescimab Data in First- ...

While progression-free survival (PFS) analysis is still immature in this study, the landmark 9-month PFS rate was 76.1% for those patients ...

What diseases does Ivonescimab treat?

The comprehensive safety data, derived from global clinical trials, underscores the balance between potent antitumor efficacy and manageable ...

ak117-hnscc.pdf

• Here, we present data on the efficacy and safety of ivonescimab, both with and without ligufalimab, in patients with PD-L1–positive R/M ...