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Advanced Malignant Solid TumorPhase 1NCT06166472

A Study to Evaluate the Safety, Tolerance, Pharmacokinetics, and Preliminary Antineoplastic Activity of AK132 in Advanced Malignant Solid Tumor

A Phase 1 study testing AK132 in people with Advanced Malignant Solid Tumor, run by Akeso at 7 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This is A Phase I Study to Evaluate the Safety, Tolerance, Pharmacokinetics, and Preliminary Antineoplastic Activity of The anti-CLDN18.2 and CD47 Bispecific Antibody AK132 in Advanced Malignant Solid Tumor Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Advanced Malignant Solid Tumor
What is being tested?
AK132
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
72 participants
Where
7 sitesChina
Study dates
12 Dec 2023to 24 Jul 2026
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • The subjects voluntarily participated in the study with full informed consent and signed written informed consent form.
  • Males or females aged ≥ 18 to ≤ 75 years at the time of signing informed consent.
  • Histologically and/or cytologically confirmed locally advanced unresectable or metastatic malignant solid tumors.
  • The interval between the end of the last systemic anti-tumor treatment and the first dose should be at least 3 weeks.
  • Subjects in the dose expansion phase are required to provide tumor tissue samples.
  • At least one measurable tumor lesion per RECIST v1.1.
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  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Life expectancy ≥ 3 months.
  • Adequate organ function as assessed in the laboratory tests.
  • Women of childbearing potential must have a negative serum pregnancy test within 7 days prior to the first dose and agree to take effective contraception measures during the study drug administration and within 120 days after the last dose. Male patients with female partners of childbearing potential must agree to take effective contraception measures during the study drug administration and within 120 days after the last dose.

Who cannot join

  • There is active or untreated brain metastases,Meningeal metastases, spinal cord compression, or leptomeningeal disease.
  • Presence of clinically symptomatic pleural effusion, pericardial effusion, or ascites requiring frequent drainage (≥ 1/month).
  • Patients who, in the opinion of the investigator, have symptoms or signs suggestive of clinically unacceptable deterioration of the primary disease at the time of screening.
  • gastrointestinal perforation or gastrointestinal fistula within 6 months before the first dose.
  • clinically significant bleeding symptoms or a clear tendency to bleed within 4 weeks before the first dose.
  • Active malignant tumors within the past 3 years, except for tumors in this study and scured local tumors.
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  • History of hemolytic anemia due to any cause within 3 months before the first dose of study drug.
  • Have a history of defects in red blood cell or hemoglobin production or metabolism.
  • Major surgery other than the diagnosis of solid tumors within 28 days prior to the first dose or major surgery is expected during the study.
  • Clinically significant cardiovascular or cerebrovascular disease.
  • Presence of ≥ Grade 2 peripheral neuropathy as defined by NCI CTCAE v5.0.
  • Presence of active diverticulitis.
  • Patients with serious neurological or psychiatric disorders.
  • Pregnant or lactating women.
  • Patients who received palliative local therapy for any tumor lesions within 2 weeks prior to the first dose;and Chinese herbal medicine or traditional Chinese medicinal products with anti-tumor indications within 2 weeks prior to the first dose.
  • Serious adverse reactions in subjects who have previously received anti-PD-1/PD-L1/CTLA-4 or any other immunotherapy or immuno-oncology (IO) drug.
  • Patients who require systemic treatment with glucocorticoids (> 10 mg/day prednisone or equivalent) or other immunosuppressive drugs within14 days prior to the first dose.
  • Unresolved toxicities during prior anti-tumor therapy with the exception of alopecia/pigmentation.
  • Subjects with a known history of severe hypersensitivity to other monoclonal antibodies. A known history of allergy or hypersensitivity to AK132 or any of its components.
  • Previous use of any antineoplastic drug targeting the CD47-SIRPα pathway or Claudin18.2.
  • Active autoimmune disease requiring systemic treatment within 2 years prior to the start of study treatment, or autoimmune diseases that may relapse or require scheduled treatment as judged by the Investigator.
  • Known active pulmonary tuberculosis.
  • Patients with active hepatitis B or active hepatitis C.
  • Known medical history of immunodeficiency or positive HIV test.
  • Known presence of interstitial lung disease or noninfectious pneumonitis that is currently symptomatic or requires prior systemic glucocorticoid therapy that, in the judgment of the Investigator, may affect the assessment or management of toxicity related to study treatment.
  • Patients with active infection, including those requiring intravenous antibiotics or antifungal therapy for 2 weeks prior to first dose, and unexplained fever during screening (CTCAE≥1, except those determined by the investigator to be neoplasmic).
  • Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation.
  • Live vaccines were administered within 28 days prior to the first dose or were planned to be administered during the study period.
  • Concurrent participation in another clinical study, unless it is an observational, non-interventional clinical study or the follow-up period of an interventional study.
  • Any condition that, in the opinion of the Investigator, may result in a risk when receiving the study drug, or would interfere with the evaluation of the study drug or the safety of patients, or the interpretation of the study results.

Trial locations and contacts

7 sites in 1 country.

Zhifang Yao, M.D. contact

+86-0760-89873999

clinicaltrials@akesobio.com

7 sites in 1 country

China7 sites

  • Hunan Provincial Cancer Hospital

    Changsha, Hunan, 410000

    Yongchang Zhang, M.D.

    Yongchang Zhang, M.D.

  • Fujian Provincial Cancer Hospital

    Fuzhou, Fujian, 350000

    Yu Lin, M.D.

    Yu Lin, M.D.

  • Sun Yat-Sen University Cancer Center, Guangzhou, China

    Guangzhou, Guangdong, 510060

    Ruihua Xu, M.D.

    Ruihua Xu, M.D.

  • Southern Medical University Nanfang Hospital

    Guangzhou, Guangdong, 510080

    Guoxin Li, M.D.

    Guoxin Li, M.D.

  • The Second Affiliated Hospital of Guangzhou Medical University

    Guangzhou, Guangdong, 510220

    Jingqi Chen, M.D.

    Jingqi Chen, M.D.

  • Huazhong University of Science and Technology Tongji Medical College Affiliated Union Hospital

    Wuhan, Hubei, 430000

    Tao Zhang, M.D.

    Tao Zhang, M.D.

  • Xiangyang Central Hospital

    Xiangyang, Hubei, 441100

    Tienan Yi, M.D.

    Tienan Yi, M.D.

Other trials in China

About this study

Official title: A Phase I Study to Evaluate the Safety, Tolerance, Pharmacokinetics, and Preliminary Antineoplastic Activity of The Anti-CLDN18.2 and CD47 Bispecific Antibody AK132 in Advanced Malignant Solid Tumor

This is A Phase I Study to Evaluate the Safety, Tolerance, Pharmacokinetics, and Preliminary Antineoplastic Activity of The anti-CLDN18.2 and CD47 Bispecific Antibody AK132 in Advanced Malignant Solid Tumor

Being tested
AK132

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AK132Drug

    IV infusion, specified dose on specified days.

Study groups in NCT06166472
Study groupRoleWhat they receive
AK132ExperimentalEach subject will receive a single dose of AK132 every 2-week cycle (Q2W).
Receives: Drug: AK132

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. dose-limiting toxicity （DLT）、adverse event（AE）、serious adverse event（SAE）

    incidence and severity of DLT, adverse events (AE), serious adverse events (SAE)

    Measured: Up to 2 years

  2. Maximum tolerated dose (MTD),RP2D

    Maximum tolerated dose (MTD), Recommended dose for phase II trial

    Measured: Up to 2 years

Secondary outcomes (8)

  1. Pharmacokinetic

    The PK parameters include serum concentrations of AK132 at different timepoints after AK132 administration.

    Measured: Up to 2 years

  2. Immunogenicity assessmen

    The immunogenicity of AK132 will be assessed by summarizing the number and percentage of subjects who develop detectable antidrug antibodies (ADAs).

    Measured: Up to 2 years

  3. Objective response rate (ORR)

    ORR is the proportion of subjects with CR or PR based on RECIST v1.1

    Measured: Up to 2 years

  4. Duration of response (DoR)

    Duration of response is defined as the duration from the first documentation of objective response to the first documented disease progression (based on RECIST Version 1.1) or death due to any cause, whichever occurs first.

    Measured: Up to 2 years

  5. Disease control rate (DCR)

    DCR is defined as the proportion of subjects with CR, PR, or SD (based on RECIST Version 1.1).

    Measured: Up to 2 years

  6. Time to response (TTR)

    Time to response (TTR) is defined as the time from the start of the treatment to the first objective tumor response observed for patients who achieved CR or PR (based on RECIST Version 1.1).

    Measured: Up to 2 years

  7. Progression-free survival (PFS)

    PFS is defined as the time from the start of treatment until the first documentation of disease progression or death due to any cause, whichever occurs first (based on RECIST Version 1.1).

    Measured: Up to 2 years

  8. Overall survival (OS)

    OS defined as the time from the first dose to death from any cause.

    Measured: Up to 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Dec 2023
  2. Study start12 Dec 2023 (estimated)
  3. Primary completion24 Apr 2026 (estimated)
  4. Study completion24 Jul 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
72 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06166472
Sponsor's protocol ID
AK132-101
Status last verified
Dec 2023
First submitted
23 Nov 2023
Last updated
12 Dec 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing AK132 in people with Advanced Malignant Solid Tumor, run by Akeso at 7 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 12 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Zhifang Yao, M.D. (+86-0760-89873999, clinicaltrials@akesobio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

dose-limiting toxicity （DLT）、adverse event（AE）、serious adverse event（SAE） (time frame: Up to 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06166472.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2023.

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