3+3 Dose escalation arm with PRJ1-3024 which will begin with 2 subjects treated at the lowest planned dose level PRJ1-3024 is administered orally once daily. The starting dose is 80mg/day.

PRJ1-3024 is provided as capsules and is administered orally once a day.

PRJ1-3024

Yang Xu

Jason Henry, MD

Cesar Perez, MD

Alexander Starodub, MD

Anthony Vandross, MD

Daruka Mahadevan, MD, PhD

Alexander Spira, MD

Yang Xu, PhD

This is a Phase I, multicenter, open-label, 3+3 dose escalation study to determine the safety and preliminary efficacy of PRJ1-3024 in subjects with relapsed/refractory solid tumors.

The study will evaluate the safety, tolerability, PK, and pharmacodynamics of PRJ1-3024 and will determine the maximum tolerated dose in subjects with advanced solid tumors.

PRJ1-3024 will be evaluated as an oral therapeutic that tests the anti-tumor activity of PRJ1-3024 in patients with solid tumors and has not yet been tested in humans.

This study will find the safe and tolerable recommended dose in subjects with advanced solid tumors as a open-label, 3+3 dose escalation study.

This is a Phase 1, open label, 3+3 dose escalation study to determine the safety and preliminary efficacy of PRJ1-3024.

A Phase I Study, Evaluating the Safety, Pharmacokinetics and Efficacy of PRJ1-3024 in Subjects With Advanced Solid Tumors

A Phase I, First-In-Human, Open-Label Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of PRJ1-3024 in Subjects With Advanced Solid Tumors

Safety listings and pharmacokinetic listings will be used for evaluation

Characterized by type, seriousness, relationship to study treatment, timing, and severity.

to estimate the accumulation of PRJ1-3024 from time 0 to the time of last quantifiable concentration after multiple administration

estimated by the proportion of subjects having a complete response (CR) or partial response (PR) with use of RECIST v1.1 criteria.

defined as time from the first occurrence of a documented objective response to the time of relapse or death from any cause.

Area under the concentration-time curve AUC from time 0 to the time of the last quantifiable concentration

assessed as time from time 0 to the time of the last quantifiable concentration

Zhuhai Yufan Biotechnologies Co., Ltd

3+3 Dose escalation arm with PRJ1-3024 which will begin with 2 subjects treated at the lowest planned dose level. PRJ1-3024 is administered orally once daily. The starting dose is 80mg/day.

Upon completing Phase 1 and depending on data obtained, dose expansion may proceed in Phase 2 with several cohorts enrolled to confirm the tolerability of the RP2D of PRJ1-3024 (determined in Phase 1). PRJ1-3024 is administered orally once daily. The starting dose is determined by clinical effecacy data from Phase 1, and treatment may continue for up to 2 years as long as the subject experiences clinical benefit in the opinion of the Investigator and shows no signs or symptoms of unequivocal progression of disease.

Liting Lai

Yanru Qin

Yongsheng Wang

Ji Zhu

Lin Shen, Dr.

Guanghai Dai

Hui ouyang, Dr.

This is a multicenter, open-label study to assess the safety and preliminary efficacy and to determine the maximum tolerated dose (MTD) or maximum administration dose (MAD) and recommended Phase 2 doses (RP2D) of PRJ1-3024 in subjects with relapsed/refractory solid tumors. The study consists of two parts, one is a 3+3 dose escalation study and another is a pharmaceutical extension of RP2D.

Using dose escalation, the study will evaluate the safety, tolerability, PK, and pharmacodynamics of PRJ1-3024 and will determine the maximum tolerated dose in subjects with advanced solid tumors.

Participants with advanced solid tumor will receive PRJ1-3024 daily as an oral therapy and test the impact of of PRJ1-3024 on tumors.

This study will find the safe and tolerable recommended dose in subjects with advanced solid tumors in a open-label, 3+3 dose escalation study and use the RP2D to assess the preliminary efficacy of PRJ1-3024 in a long-term extension study.

Part 1 is a Phase 1, open label, 3+3 dose escalation study to determine the safety and preliminary efficacy of PRJ1-3024. Upon completing Phase 1 and depending on data obtained, dose expansion may proceed in Phase 2 to confirm the tolerability and efficacy of the RP2D of PRJ1-3024 .

A Phase I/II Study to Evaluate the Safety, Pharmacokinetics and Efficacy of PRJ1-3024 in Subjects With Advanced Solid Tumors

A Phase 1/2, Open-label Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Prime Efficacy of PRJ1-3024 in Subjects With Advanced Solid Tumors

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Phase I Study, Evaluating the Safety, Pharmacokinetics and Efficacy of PRJ1-3024 in Subjects With Advanced Solid Tumors	NCT05159700	Advanced Solid ... Advanced Solid ...	PRJ1-3024	18 Years -	Zhuhai Yufan Biotechnologies Co., Ltd
A Phase I/II Study to Evaluate the Safety, Pharmacokinetics and Efficacy of PRJ1-3024 in Subjects With Advanced Solid Tumors	NCT05315167	Advanced Solid ... Advanced Solid ...	PRJ1-3024	18 Years -	Zhuhai Yufan Biotechnologies Co., Ltd
A Phase I/II Study to Evaluate the Safety, Pharmacokinetics and Efficacy of PRJ1-3024 in Subjects With Advanced Solid Tumors	NCT05315167	Advanced Solid ... Advanced Solid ...	PRJ1-3024	18 Years -	Zhuhai Yufan Biotechnologies Co., Ltd
A Phase I/II Study to Evaluate the Safety, Pharmacokinetics and Efficacy of PRJ1-3024 in Subjects With Advanced Solid Tumors	NCT05315167	Advanced Solid ... Advanced Solid ...	PRJ1-3024	18 Years -	Zhuhai Yufan Biotechnologies Co., Ltd

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