NCT05528055

A Phase I Study to Investigate the Safety, Tolerability, Preliminary Efficacy and Pharmacokinetics(PK) of SCR-6920 Capsule in Patients With Advanced Malignant Tumors

Recruiting now Phase 1 Last updated 2 September 2022

What this trial tests

Phase 1 trial testing SCR-6920 capsule in Solid Tumor in 122 participants. Currently enrolling.

Timeline

18 May 2022

Primary endpoint
1 October 2027

1 October 2027

Quick facts

Lead sponsor	Jiangsu Simcere Pharmaceutical Co., Ltd.
Phase	Phase 1
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	non randomized
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	122
Start date	18 May 2022
Primary completion	1 October 2027
Estimated completion	1 October 2027
Sites	1 location across China

Drugs / interventions tested

• SCR-6920 capsule — full drug profile →
• SCR-6920 capsule — full drug profile →
• SCR-6920 capsule — full drug profile →
• SCR-6920 capsule — full drug profile →

Conditions studied

• Solid Tumor — all drugs for Solid Tumor →
• Non Hodgkin Lymphoma — all drugs for Non Hodgkin Lymphoma →

Sponsor

Jiangsu Simcere Pharmaceutical Co., Ltd. — full company profile →

Who can join

Adults 18 to 75, any sex, with Solid Tumor or Non Hodgkin Lymphoma. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Dose limiting toxicity(DLT)
  Time frame: Up to 28 days
  DLT will be evaluated within 28 days since first dose. The number of DLTs will be used to determine the maximum tolerated dose (MTD).
• Overall Response Rate (ORR)
  Time frame: Up to approximately 1 years
  Participants with solid tumor: ORR based on RECIST1.1 criteria; Participants with NHL: ORR based on Lugano criteria

Sponsor's own description

A Phase 1, open label, multi center, dose escalation and expansion study will assess the safety, tolerability, PK, and preliminary efficacy of SCR-6920 capsule in participants with advanced malignant tumors. The purpose of the study is to identify the maximum tolerated dose (MTD) and/or the recommended Phase 2 dose (RP2D), and to confirm the tolerability and preliminary efficacy of SCR-6920 in participants with advanced solid tumors and relapsed/refractory non-Hodgkin lymphoma(NHL).

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Amino acid metabolism in health and disease.
   Ling ZN, Jiang YF, Ru JN, Lu JH, et al · · 2023 · cited 291× · PMID 37699892 · DOI 10.1038/s41392-023-01569-3
2. Epigenetics-targeted drugs: current paradigms and future challenges.
   Dai W, Qiao X, Fang Y, Guo R, et al · · 2024 · cited 131× · PMID 39592582 · DOI 10.1038/s41392-024-02039-0
3. The potential and challenges of targeting <i>MTAP</i>-negative cancers beyond synthetic lethality.
   Bray C, Balcells C, McNeish IA, Keun HC. · · 2023 · cited 26× · PMID 37795443 · DOI 10.3389/fonc.2023.1264785
4. Targeting pre-mRNA splicing in cancers: roles, inhibitors, and therapeutic opportunities.
   Araki S, Ohori M, Yugami M. · · 2023 · cited 19× · PMID 37342192 · DOI 10.3389/fonc.2023.1152087
5. Therapeutic targeting of chromatin alterations in leukemia and solid tumors.
   Perner F, Berg T, Sasca D, Mersiowsky SL, et al · · 2026 · cited 11× · PMID 40181550 · DOI 10.1002/ijc.35389
6. PRMT5 as a Potential Therapeutic Target in MYC-Amplified Medulloblastoma.
   Kumar D, Jain S, Coulter DW, Joshi SS, et al · · 2023 · cited 11× · PMID 38136401 · DOI 10.3390/cancers15245855
7. PRMT1 and PRMT5: on the road of homologous recombination and non-homologous end joining.
   Yin S, Liu L, Gan W. · · 2023 · cited 9× · PMID 37663901 · DOI 10.1007/s42764-022-00095-w
8. Perspectives on cancer therapy-synthetic lethal precision medicine strategies, molecular mechanisms, therapeutic targets and current technical challenges.
   Peng S, Long M, Chen Q, Yin Z, et al · · 2025 · cited 8× · PMID 40240755 · DOI 10.1038/s41420-025-02418-8