A Study to Evaluate the Safety, Pharmacokinetics, and Antitumor Activity of AK127 in Combination With AK104 in Advanced and Metastatic Solid Tumours
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|ClinicalTrials.gov Identifier: NCT05021120|
Recruitment Status : Recruiting
First Posted : August 25, 2021
Last Update Posted : January 9, 2023
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|Condition or disease||Intervention/treatment||Phase|
|Advanced or Metastatic Solid Tumours||Drug: AK127 Drug: AK104||Early Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||143 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Sequential Assignment|
|Masking:||None (Open Label)|
|Masking Description:||None (open Label)|
|Official Title:||A Phase 1a/1b, Multicenter, Open-Label, Dose-Escalation and Dose-Expansion Study to Evaluate the Safety, Pharmacokinetics, and Anti-tumour Activity of AK127 in Combination With AK104 in Subjects With Advanced or Metastatic Solid Tumours|
|Actual Study Start Date :||October 12, 2021|
|Estimated Primary Completion Date :||January 10, 2025|
|Estimated Study Completion Date :||April 7, 2025|
Subjects will receive AK127 by intravenous administration
After AK127 infusion, on the same day subjects will receive AK104 by intravenous administration
- Incidence and Nature of Adverse Events (AEs) [ Time Frame: From the time of informed consent signed through to 90 days after end of treatment ]An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product temporally associated with the use of study treatment, whether or not considered related to the study treatment.
- Number of participants with a Dose Limiting Toxicity (DLT) [ Time Frame: Within the first six weeks of treatment ]DLTs will be assessed during the first treatment cycle and assessed as having a suspected relationship to study drug according to pre-specific criteria in the protocol.
- Objective response rate (ORR) [ Time Frame: Up to 2 years ]The ORR is defined as the proportion of subjects with confirmed CR or confirmed PR, based on RECIST Version 1.1.
- Disease control rate (DCR) [ Time Frame: Up to 2 years ]Progression-free survival is defined as the time from the start of treatment with AK127 + AK104 until the first documentation of disease progression or death due to any cause, whichever occurs first.
- Progression-free survival (PFS) [ Time Frame: Up to 2 years ]Progression-free survival 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.
- Overall survival (OS) [ Time Frame: Up to 2 years ]Overall survival is defined as the time from the start of treatment until death due to any cause.
- Area under the curve (AUC) of AK127+AK104 for assessment of pharmacokinetics [ Time Frame: From first dose of treatment through to 90 days after end of treatment ]The endpoints for assessment of PK including serum concentrations of AK127+AK104 at different timepoints after treatment administration.
- Maximum observed concentration (Cmax) of AK127 + AK104 [ Time Frame: From first dose of treatment through to 90 days after end of treatment. ]The endpoints for assessment of PK of AK127+AK104 include serum concentrations of AK127+AK104 at different timepoints after treatment administration.
- Minimum observed concentration (Cmin) of AK127+AK104 [ Time Frame: From first dose of treatment through to 90 days after end of treatment ]The endpoints for assessment of PK of AK127+AK104 include serum concentrations of AK127+AK104 at different timepoints after treatment administration.
- Number of subjects who develop detectable anti-drug antibodies (ADAs) [ Time Frame: From first dose of treatment through to 90 days after end of treatment ]The immunogenicity of AK127+AK104 will be assessed by summarizing the number of subjects who develop detectable anti-drug antibodies (ADAs).
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Written and signed informed consent
- In Phase 1a, patients with relapsed or refractory advanced solid malignancies
- In Phase 1b, patients must have received no more than three prior lines of systemic therapy
- Subject must have at least one measurable lesion according to RECIST Version1.1.
- Eastern Cooperative Oncology Group (ECOG) Performance Score of 0 or 1.
- Available archived or fresh tumor tissue
- Adequate organ function.
- For dose-expansion cohorts (Phase 1b), subjects must be willing to provide two fresh biopsy samples (pre-treatment and on treatment), where clinically appropriate.
- Females of childbearing potential and non-sterilized males who are sexually active must use an effective method of contraception from screening until 120 days after final dose of investigational product.
- History of severe hypersensitivity reactions to other mAbs.
- Subjects with a condition requiring systemic treatment with either corticosteroid (> 10 mg daily ) or other immunosuppressive medications within 2 weeks of study drug administration.
- Prior use of approved or investigational anti-TIGIT, anti-PVRIG, or anti-CD96 therapy
- Receiving any Other anticancer therapy (e.g., chemotherapy, radiotherapy, biologic or hormonal therapy for cancer treatment. etc.) within 4 weeks prior to the first dose of treatment
- Any major surgery within 4 weeks prior to the first dose of treatment
- Receiving agents with immunomodulatory effect within 2 weeks prior to the first dose of treatment.
- Active or prior documented inflammatory bowel disease
- History of organ transplant.
- History of interstitial lung disease, noninfectious pneumonitis except for those induced by radiation therapies.
- Known active hepatitis B or C infections or history of HIV.
- Receipt of live attenuated vaccines within 4 weeks prior to the first dose of investigational product.
- Patients with severe heart and lung dysfunction.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05021120
|Contact: Baiyong Li||+86 (0760) 8987 firstname.lastname@example.org|
|Contact: Dennis Xiaemail@example.com|
|Ashford Cancer Centre Research||Recruiting|
|Southside Cancer Care Centre||Recruiting|
|The Kinghorn Cancer Centre, St Vincents Hospital Sydney||Recruiting|
|Responsible Party:||Akesobio Australia Pty Ltd|
|Other Study ID Numbers:||
|First Posted:||August 25, 2021 Key Record Dates|
|Last Update Posted:||January 9, 2023|
|Last Verified:||January 2023|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|