Clinical trial · Interventional
A Study to Investigate the Safety and Tolerability of SCR-6920 Capsule in Patients With Advanced Malignant Tumors
A Phase I Study to Investigate the Safety, Tolerability, Preliminary Efficacy and Pharmacokinetics(PK) of SCR-6920 Capsule in Patients With Advanced Malignant Tumors
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non Hodgkin Lymphoma | Non-Hodgkin Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SCR-6920 capsule | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Dose escalation
- description
- Participants will receive SCR-6920 capsule orally at escalating doses, till the maximum tolerated dose level is reached, and the recommended phase 2 dose(RP2D) will be determined.
- interventionNames
- Drug: SCR-6920 capsule
- type
- EXPERIMENTAL
- label
- Dose expansion: non small cell lung cancer(NSCLC)
- description
- Participants will receive SCR-6920 capsule orally at the recommended phase 2 dose
- interventionNames
- Drug: SCR-6920 capsule
- type
- EXPERIMENTAL
- label
- Dose expansion: NHL
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically or cytologically confirmed locally advanced or metastatic solid tumors or histopathologically confirmed NHL * Relapsed/refractory solid tumor or relapsed/refractory NHL who have progressed during or after standard therapy or for which treatment is not tolerated, not suitable, not available. * At least one evaluable or measurable lesion (as defined in the protocol). * ECOG Performance Status 0 or 1. * Life expectancy ≥12 weeks. * Adequate organ function (as defined in the protocol). * Reproductive criteria (as defined in the protocol). Exclusion Criteria: * Any clinically significant gastrointestinal (GI) abnormalities that may alter absorption. * Major surgery, systemic anti-cancer therapy or investigational drug(s) within 4 weeks prior to study entry. Radiation therapy within 2 weeks prior to study entry. * Adverse reactions from previous anti-tumor therapy have not yet recovered to ≤ grade 1(excluding hair loss, peripheral neurotoxicity caused by chemotherapy have recovered to ≤ grade 2 ). * Autologous hematopoietic stem cell transplantation was performed within 9 months prior to the first dose. * History of a second malignancy within 2 years (as defined in the protocol). * Active uncontrolled or symptomatic lung disease (as defined in the protocol). * Intracranial hypertension or active uncontrolled or symptomatic CNS metastases. * Known or suspected hypersensitivity to study medications. * Known active uncontrolled or symptomatic CNS metastases. * The investigator determined that the patient should not participate in the study. * Known mental illness or substance abuse that may disrupt therapy. * Clinically significant cardiac abnormalities (as defined in the protocol). * Gestating or Lactating women. * Pleural effusion, pericardial effusion or ascites that need diuretics or draining within 2 weeks prior to first dose. * The patient is currently using a drug known to be a strong inhibitor or inducer of CYP3A4.
References
Publications (0)
Data not yet available