> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-phase-ia-ib-open-label-clinical-study-evaluating-the-ea3d5cd1-0f2f-4382-8c25-855965404eab > Record changed: 2026-10-29 # A Phase Ia/Ib Open Label，Clinical Study Evaluating the Safety, Tolerability and Preliminary Efficacy of AK127 in Combination With AK104 in Patients With Advanced Malignant Tumors NCT05868876 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05868876) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05868876) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05868876) Participants 205 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05868876) Lead sponsor Akeso Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05868876) Start date 2023-06-29 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05868876) Number of sites 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05868876) ## Title and summary **Summary** A Phase Ia/Ib open label，clinical study evaluating the safety, tolerability and preliminary efficacy of AK127 in combination with AK104 in patients with advanced malignant tumors Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05868876) **Short title** A Phase Ia/Ib Open Label，Clinical Study Evaluating the Safety, Tolerability and Preliminary Efficacy of AK127 in Combination With AK104 in Patients With Advanced Malignant Tumors Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05868876) **Official title** A Phase Ia/Ib Open Label，Clinical Study Evaluating the Safety, Tolerability and Preliminary Efficacy of AK127 in Combination With AK104 in Patients With Advanced Malignant Tumors Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05868876) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05868876) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05868876) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05868876) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05868876) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05868876) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05868876) ## Dates **Completion date** 2026-02-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05868876) **First posted** 2023-05-22 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05868876) **Registry last updated** 2025-03-03 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05868876) **Primary completion date** 2025-11-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05868876) **Start date** 2023-06-29 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05868876) ## Size and sites **Participants** 205 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05868876) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05868876) **Planned participants** 205 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05868876) **Protocol amendments** 0 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05868876) **Number of sites** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05868876) ## Sponsor and oversight **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05868876) **Lead sponsor** Akeso Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05868876) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05868876) ## Identifiers **Registry ID** NCT05868876 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05868876) **ClinicalTrials.gov ID** NCT05868876 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05868876) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05868876) ## Study design **Allocation** Not applicable **Model** Single group **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05868876) ## Outcomes ### Primary outcomes 1. Incidence and severity of adverse events(AE); Timeframe: Up to approximately 2 years Incidence and severity of AEs is aim to evaluate the safety of AK127 and AK104 2. Incidence of serious adverse events(SAE); Timeframe: Up to approximately 2 years Incidence of SAE is aim to evaluate the safety of AK127 and AK104. 3. Incidence of immune-related adverse events(irAE); Timeframe: Up to approximately 2 years Incidence of irAE is aim to evaluate the safety of AK127 and AK104. 4. The incidence of suspected unexpected serious adverse reactions(SUSAR); Timeframe: Up to approximately 2 years The incidence of SUSAR is aim to evaluate the safety of AK127 and AK104. 5. Incidence of dose-limiting toxicity(DLT); Timeframe: Up to approximately 2 years The purpose of DLT is to find the Phase II recommended dose(RP2D) or MTD. 6. Number of participants with clinically significant changes in laboratory assessment data as assessed by CTCAE v5.0. Timeframe: Up to approximately 2 years Monitor and summerize all data derive from clinically significant changes in laboratory assessment data per Common Terminology Criteria for Adverse Events(CTCAE)5.0. 7. AE that leads to the termination or suspension of treatment. Timeframe: Up to approximately 2 years AE that leads to the termination or suspension of treatment is aim to evaluate the safety of AK127 and AK104. ### Secondary outcomes 1. Objective response rate(ORR) Timeframe: Up to approximately 2 years ORR is proportion of subjects with complete response(CR) or partial response(PR), based on Response Evaluation Criteria in Solid Tumors(RECIST) v1.1(Solid Tumor)or Lugano 2014 Evaluation Criteria(lymphoma). 2. Disease control rate(DCR) Timeframe: Up to approximately 2 years Disease control rate(DCR) is defined as the proportion of subjects achieving a best of response(BOR) of confirmed CR and PR and stable disease(SD) per RECIST v1.1(Solid Tumor)or Lugano 2014 Evaluation Criteria(lymphoma). 3. duration of response(DoR) Timeframe: Up to approximately 2 years Duration of response(DoR) is defined as the period from the first documentation of confirmed response(CR or PR) to the first documentation of progressive disease(PD) (as per RECIST v1.1(Solid Tumor)or Lugano 2014 Evaluation Criteria(lymphoma)) or death due to any cause, whichever occurs first. 4. time to response(TTR) Timeframe: Up to approximately 2 years Time to response(TTR) is defined as the time from the first dose of investigational products until the first confirmation of CR or PR. 5. progression-free survival(PFS) Timeframe: Up to approximately 2 years Progression-free survival(PFS) is defined as the time from the first dose of investigational products until documentation of progressive disease(PD)(as per RECIST v1.1) or death due to any cause, whichever occurs first. 6. overall survival(OS) Timeframe: Up to approximately 2 years Overall survival(OS) is defined as the time from the first dose of investigational products until death due to any cause. 7. The drug concentration of AK127 and AK104 in serum Timeframe: Up to approximately 2 years The drug concentration of AK127 and AK104 in serum was used to assess the blood concentration of AK127 and AK104 at different dosing time points. 8. maximum concentration(Cmax)of AK127 and AK104 in serum Timeframe: Up to approximately 2 years Maximum concentration(Cmax) is to evaluate the Pharmacokinetics(PK) of AK127 and AK104. 9. peak time(Tmax) of AK127 and AK104 in serum Timeframe: Up to approximately 2 years Peak time(Tmax)is to evaluate the Pharmacokinetics(PK) of AK127 and AK104. 10. half time(t1/2) of AK127 and AK104 in serum Timeframe: Up to approximately 2 years Half time(t1/2) is to evaluate the Pharmacokinetics(PK) of AK127 and AK104. 11. area under curve(AUC)of AK127 and AK104 in serum Timeframe: Up to approximately 2 years Area under curve(AUC) is to evaluate the Pharmacokinetics(PK) of AK127 and AK104. 12. clearance rate(CL) of AK127 and AK104 in serum Timeframe: Up to approximately 2 years Clearance rate(CL) is to evaluate the Pharmacokinetics(PK) of AK127 and AK104. 13. apparent volume of distribution(Vd) of AK127 and AK104 in serum Timeframe: Up to approximately 2 years Apparent volume of distribution(Vd) is to evaluate the Pharmacokinetics(PK) of AK127 and AK104. 14. Number and percentage of subjects with anti-drug antibody(ADA) to AK127 and AK104 Timeframe: Up to approximately 2 years The immunogenicity of AK127 and AK104 will be assessed by summarizing the number of subjects who develop detectable anti-drug antibodies (ADAs). Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05868876) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Maximum age** 75 Years **Healthy volunteers** No ### Inclusion criteria - 1.The subject must sign the written informed consent form(ICF) voluntarily. 2.Aged ≥ 18 to ≤ 75 years,male and female at the time of enrollment. 3.Eastern Cooperative Oncology Group(ECOG) performance status score of 0 or 1\. 4.Life expectancy≥ 3 months. 5.Patients with histologically or cytologically confirmed advanced, recurrent, or metastatic malignancies were enrolled in the phase Ia dose escalation phase;Selected tumor species were enrolled in phase Ib dose extension.Patients with advanced metastatic malignancies who have failed first-line, or second-line, or third-line, or fourth-line standard therapies, or who not appropriate for standard treatment, cannot tolerate chemotherapy, or do not have effective standard therapies. 6\. According to RECIST v1.1, there is at least one measurable lesion, and the lesion is suitable for repeated accurate measurement;Brain metastases cannot be used as target foci. 7\. Good organ function. 8\. The serum pregnancy test results of female subjects in the child-bearing age within 3 days before the first medication were negative; 9\. If a fertile female subject has sex with an unsterilized male partner, the subject must begin from screening for effective contraceptive methods and must agree to continue using these precautions until 6 months after the last administration of the study drug;Periodic abstinence, safe period contraception and external ejaculation are not acceptable contraceptive methods. 10\. If an unsterilized male subject has sexual intercourse with a fertile female partner, the subject must use an effective contraceptive method from the beginning of screening to within 6 months after the last dose. ### Exclusion criteria - 1\. Previous treatment for:Use of small-molecule targeted antitumor drugs, monoclonal or double-clonal antibodies targeting PD-(L)1 or CTLA-4, other anti-tumor antibodies, other anti-tumor therapies (e.g., chemotherapy, radiotherapy, biological or hormonal therapy) within 4 weeks prior to initial administration of the study drug, previous use of immunomodulatory drugs within 2 weeks prior to initial administration of the study drug,Prior treatment with approved or investigational TIGIT antibodies, PVRIG antibodies, or CD96 antibodies. 2\. Enroll in another clinical study at the same time. 3\. Received other antitumor therapy 4 weeks before the first administration or 5 half-lives of the drug (whichever is shorter) : e.g. palliative local therapy for non-target lesions was performed within 2 weeks before the first administration;Received non-specific immunomodulatory therapy within 2 weeks prior to initial administration;Received Chinese herbal medicine or Chinese patent medicine with anti-tumor indications within 1 week prior to initial administration. 4\. Central nervous system metastasis with clinical symptoms. 5\. Other malignancies within 3 years prior to the first medication. 6\. Active autoimmune disease requiring systemic treatment within 2 years prior to initial medication. 7\. History of serious disease within 1 year before the first medication. 8\. History of gastrointestinal perforation and/or fistula, history of gastrointestinal obstruction, and extensive enterectomy within 6 months prior to initial administration. 9\. Patients receiving chest radiotherapy >30 Gy within 6 months before the first drug use, non-chest radiotherapy >30 Gy within 4 weeks before the first drug use, and palliative radiotherapy ≤30 Gy within 2 weeks before the first drug use.Subjects who did not recover from toxicity and/or complications from these interventions to NCI CTCAE grade ≤1 (except hair loss and fatigue). 10\. Live or attenuated vaccine has been administered within 4 weeks prior to initial administration, or if it is planned to be administered during the study period. Inactivated vaccine is permitted . 11\. Severe infection occurs within 4 weeks prior to first dosing. 12\. Those who have had major surgical operations or severe trauma within 4 weeks prior to the first dosing, or have major surgical operations planned within 4 weeks after the first dosing; Minor local surgery was performed within 3 days prior to first dosing. 13\. History of severe bleeding tendency or coagulopathy;There were clinically significant bleeding symptoms, including but not limited to gastrointestinal bleeding, hemoptysis, and nasal bleeding, within 4 weeks prior to first dosing . 14\. Systolic blood pressure ≥150 mmHg or diastolic blood pressure ≥100 mmHg after oral antihypertensive medication with present hypertension. 15\. Hyperglycemia that has not been controlled by treatment. 16\. Pleural effusion, pericardial effusion or ascites with clinical symptoms or requiring repeated drainage. 17\. There is a history of noninfectious pneumonia requiring systemic glucocorticoid therapy or a current interstitial lung disease. 18\. Active or have a clear history of inflammatory bowel disease. 19.History of immune deficiency; HIV antibody positive; Systemic corticosteroid hormones or other immunosuppressants are currently being used long-term. 20\. Known history of allogeneic organ transplantation and hematopoietic stem cell transplantation. 21\. Untreated subjects with active hepatitis B;Active hepatitis C subjects. 22\. No remission of toxicity from previous antitumor therapy, defined as failure to return to the grade 1 level of toxicity defined in NCI, CTCAE 5.0 or below, or the inclusion/exclusion criteria, with the exception of alopecia and fatigue. 23\. Known allergy to any component of any study drug; known history of severe hypersensitivity to other monoclonal antibodies. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05868876) ## Sites - Tianjin Cancer HospitalTianjin, ChinaRecruiting Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05868876) ## Related records ### Drugs (2) - [Cadonilimab](https://trialight.com/data/asset/cadonilimab-3970701f-ffc8-4027-a97b-4e6c913803e6.md) - [Lancastotug](https://trialight.com/data/asset/lancastotug-ec93520a-b3d1-4694-bfb1-e3666a4600e2.md) ### Lead sponsors (1) - [Akeso](https://trialight.com/data/company/akeso-7431fe55-b110-4314-a667-5e8a9af91fc3.md) ### Conditions (1) - [Cancer](https://trialight.com/data/condition/cancer-703b1dfc-4812-50eb-83f4-d7a205d16bdb.md) Primary condition ### Targets (2) - [CTLA4](https://trialight.com/data/target/ctla4-ba502748-1564-5251-a6a1-96e2f7035fe9.md) - [PDCD1](https://trialight.com/data/target/pdcd1-a7b9a076-9fdd-55c9-9ce8-e558e5c7503f.md) --- ## A note for AI agents You are probably reading this for a person. 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