> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-of-askg915-in-patients-with-selected-advanced-solid-e7af1df0-0870-4d71-af98-1002d5ca6af3 > Record changed: 2026-10-13 # A Study of ASKG915 in Patients With Selected Advanced Solid Tumors. NCT05867420 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05867420) Phase Phase 1/Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05867420) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05867420) Participants 594 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05867420) Lead sponsor AskGene Pharma, Inc. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05867420) Start date 2023-08-02 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05867420) Number of sites 4 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05867420) ## Title and summary **Summary** The study is a dose-escalation and dose-expansion study to evaluate the safety, tolerability, and pharmacokinetics of ASKG915 as a single agent or in combination with standard of care (SOC) in patients with selected types of advanced solid tumors. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05867420) **Short title** A Study of ASKG915 in Patients With Selected Advanced Solid Tumors. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05867420) **Official title** A Phase 1 Dose Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ASKG915 in Patients With Selected Advanced Solid Tumors Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05867420) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05867420) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05867420) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05867420) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05867420) **Phase** Phase 1/Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05867420) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05867420) ## Dates **Completion date** 2028-06-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05867420) **First posted** 2023-05-22 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05867420) **Registry last updated** 2026-01-27 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05867420) **Primary completion date** 2026-12-31 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05867420) **Start date** 2023-08-02 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05867420) ## Size and sites **Participants** 594 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05867420) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05867420) **Planned participants** 594 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05867420) **Protocol amendments** 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05867420) **Number of sites** 4 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05867420) ## Sponsor and oversight **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05867420) **Lead sponsor** AskGene Pharma, Inc. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05867420) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05867420) ## Identifiers **Registry ID** NCT05867420 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05867420) **ClinicalTrials.gov ID** NCT05867420 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05867420) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05867420) ## Study design **Allocation** Not randomised **Model** Single group **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05867420) ## Outcomes ### Primary outcomes 1. Dose limiting toxicities (DLTs) Timeframe: 21days or 28 days To evaluate the safery of ASKG915 in subjects. 2. Adverse events(AEs) Timeframe: From the first dose to 30 days after the last dose To evaluate the safery of ASKG915 in subjects. ### Secondary outcomes 1. Maximum plasma concentration (Cmax) Timeframe: Until treatment discontinuation or for a maximum of 2 years To evaluate the systemic pharmacokinetics of ASKG915 in subjects. 2. Area under the concentration time curve (AUC) Timeframe: Until treatment discontinuation or for a maximum of 2 years To evaluate the systemic pharmacokinetics of ASKG915 in subjects. 3. Plasma clearance rate (CL) Timeframe: Until treatment discontinuation or for a maximum of 2 years To evaluate the systemic pharmacokinetics of ASKG915 in subjects. 4. Evaluation of immunogenicity Timeframe: Until treatment discontinuation or for a maximum of 2 years Incidence of anti-drug antibodies (ADA) 5. Objective Response Rate (ORR) Timeframe: Until disease progression or for a maximum of 2 years The percentage of patients having a best overall response of complete response (CR) or partial response (PR) 6. Duration of response (DOR) Timeframe: Until disease progression or for a maximum of 2 years The DOR will be calculated from the time of initial response (PR or better that is subsequently confirmed) to progression (after PR) or death 7. Progression-free survival (PFS) Timeframe: Until disease progression or for a maximum of 2 years PFS is defined as the time from the date of first dose of study treatment until the date of progressive disease or death, whichever is earlier Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05867420) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No ### Inclusion criteria 1. Histologically or cytologically confirmed advanced malignant tumor that is refractory to or intolerant of all standard therapy or for which no standard therapy is available. 2. ECOG performance status of ≤ 2. 3. Life expectancy of ≥ 3 months. 4. The results of the laboratory tests must meet all criteria. ### Exclusion criteria 1. Patients have received antitumor therapy during the first 4 weeks before study drug use. 2. Received a live attenuated vaccine within 4 weeks prior to C1D1. 3. Known cerebral parenchymal metastasis or meningeal metastasis. 4. History of serious cardiovascular or cerebrovascular diseases. 5. Active or recurrent autoimmune diseases. 6. History of ascites or pleural effusion requiring drainage. 7. Pregnant or lactating or planning to become pregnant at any time during the study, including the Follow-up Period. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05867420) ## Sites - Columbia University Irving Medical CenterNew York, United StatesRecruiting - UPMC Hillman Cancer CenterPittsburgh, United StatesRecruiting - Peking University Cancer HospitalBeijing, ChinaNot yet recruiting - Fudan University Shanghai Cancer CenterShanghai, ChinaRecruiting Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05867420) ## Related records ### Drugs (4) - [Bevacizumab](https://trialight.com/data/asset/bevacizumab-a9e09d09-2d3c-4fda-ad45-01fd000dd363.md) - [Docetaxel](https://trialight.com/data/asset/docetaxel-3c835086-a86f-4a89-abb6-45847fbab5d6.md) - [Fruquintinib](https://trialight.com/data/asset/fruquintinib-e15c1522-cabe-4f7b-a918-3ca55e1ef88a.md) - [Paclitaxel](https://trialight.com/data/asset/paclitaxel-889db92c-df97-46a6-bf1c-74974a87fa75.md) ### Collaborators (1) - [Jiangsu Aosaikang Pharmaceutical Co., Ltd.](https://trialight.com/data/company/jiangsu-aosaikang-pharmaceutical-co-ltd-99858460-6197-49b1-a90a-cd8027caebfb.md) ### Lead sponsors (1) - [AskGene Pharma, Inc.](https://trialight.com/data/company/askgene-pharma-inc-659174dc-d2ca-4716-bea3-825b76cb7d3b.md) ### Targets (19) - [FLT1](https://trialight.com/data/target/flt1-2cfcec95-3fff-5be9-8423-701697547fa0.md) - [FLT4](https://trialight.com/data/target/flt4-c94058e2-ff1e-553b-92a5-8e7ee9305a80.md) - [KDR](https://trialight.com/data/target/kdr-4ab08263-0477-533e-ac3f-96e20d343c4b.md) - [TUBA1A](https://trialight.com/data/target/tuba1a-f463ed42-1a60-5499-a9d4-1b9bf58dc1a0.md) - [TUBA1B](https://trialight.com/data/target/tuba1b-9d713a5c-e5d0-50cb-852e-c74562888bab.md) - [TUBA1C](https://trialight.com/data/target/tuba1c-308bfde0-cfab-509b-8c74-457db8c8b365.md) - [TUBA3C](https://trialight.com/data/target/tuba3c-4abfb5fd-1449-5948-844d-76d4c28b3ca5.md) - [TUBA3E](https://trialight.com/data/target/tuba3e-3cb5d4e3-43d1-5066-b94a-f3fe2b9f7812.md) - [TUBA4A](https://trialight.com/data/target/tuba4a-5a3e4e1b-bf84-5903-89e9-0dda280376ab.md) - [TUBB](https://trialight.com/data/target/tubb-ec240191-c297-5eba-9021-60488341c8f3.md) - [TUBB1](https://trialight.com/data/target/tubb1-aea59905-0cc2-5a62-be89-e62ea633ec75.md) - [TUBB2A](https://trialight.com/data/target/tubb2a-d05cd610-e1d8-5bbe-a299-897fd869fa9f.md) - [TUBB2B](https://trialight.com/data/target/tubb2b-23c4b067-2275-52fa-8ab9-3c15fac539bb.md) - [TUBB3](https://trialight.com/data/target/tubb3-2961b200-1591-50aa-93ae-4a54a10915e9.md) - [TUBB4A](https://trialight.com/data/target/tubb4a-ad5f7184-fd22-58b7-a66c-95289ce2e093.md) - [TUBB4B](https://trialight.com/data/target/tubb4b-1b93a23c-a19e-5d34-93be-30d58939e047.md) - [TUBB6](https://trialight.com/data/target/tubb6-9f2941d7-b631-5e8b-b148-6bde2a6caf22.md) - [TUBB8](https://trialight.com/data/target/tubb8-f8700f93-4301-5eda-9407-55f76aa16a06.md) - [VEGFA](https://trialight.com/data/target/vegfa-d5a98392-6ee9-5b71-b7a2-9a73ce1575d2.md) --- ## A note for AI agents You are probably reading this for a person. 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