Clinical trial · Interventional
SG301 Safety Study in Subjects With Relapsed or Refractory Multiple Myeloma and Other Hematological Malignancies
A Phase 1 Study of SG301 in Subjects With Hematological Malignancies
NCT04684108CI-TRIAL-00121382active not recruitingPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- 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)
This is a Phase 1a/1b Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of SG301 in Patients with Relapsed or Refractory Multiple Myeloma and Other Hematological Malignancies
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 |
|---|---|---|---|
| Hematological Malignancy | Hematopoietic and Lymphoid Cell Neoplasm | ALIAS | 0.90 |
| Relapsed or Refractory Multiple Myeloma | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SG301 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- SG301
- description
- SG301 monotherapy intravenous (IV) infusion
- interventionNames
- Drug: SG301
Primary outcomes (2)
- measure
- Incidence of Treatment-Emergent Adverse Events
- timeFrame
- Through study completion, an average of one year
- description
- Number and percentage of AE which is calculated by worst CTCAE grade by CTCAE 5.0
- measure
- MTD/MAD/ RP2D
- timeFrame
- Through study completion, an average of one year
- description
- To determine the maximum tolerated dose (MTD) or maximum administered dose (MAD) for intravenous (IV) administration of SG301 in patients with relapsed or refractory multiple myeloma and other hematological malignancies; To preliminarily determine the recommended Phase 2 dose (RP2D) of SG301 given intravenously in patients with relapsed or refractory multiple myeloma and other hematological malignancies.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Understand and voluntarily sign the informed consent form (ICF). 2. Age ≥18 years. 3. Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0, 1 or 2. 4. Expected survival time of ≥3 months. 5. Patients with histologically or cytologically confirmed hematological malignancies who are relapsed or refractory to or intolerant of standard therapies. For patients with multiple myeloma: should be relapsed or refractory multiple myeloma with measurable disease 6. Adequate organ function 7. Toxicity caused by prior anti-tumor therapy recovered to Grade 0 to 1 (CTCAE 5.0), except for alopecia, controlled Grade ≤2 sensory neuropathy, lymphocytopenia, and endocrine disorders. 8. Female patients of childbearing potential and male patients whose female partners are of childbearing potential need to use at least one approved contraceptive (e.g., intrauterine device, pill, or condom) during study treatment and for at least 6 months (180 days) after the last dose; female patients of childbearing potential must have a negative blood human chorionic gonadotropin (HCG) test during screening period and must not be lactating. Exclusion Criteria: Patient Exclusion Criteria: 1. Presence of central nervous system metastatic lesions. 2. uncontrolled cardiac disease requiring treatment, congestive heart failure NYHA III or IV, unstable angina pectoris even if medically controlled, history of myocardial infarction during the last 6 months. 3. Active infection requiring antimicrobial therapy within 2 weeks prior to study drug administration. 4. Patients with active viral hepatitis (any etiology) are excluded. 5. Anticancer therapy within 5 half-lives or 2 weeks (whichever is longer) 6. Primary refractory to previous anti-CD38 therapy. 7. Major surgery within 4 weeks prior to study entry. 8. Prior or concurrent malignancy within 2 years prior to entry, other than adequately controlled skin basal cell carcinoma, cervical carcinoma in situ, breast carcinoma in situ, skin squamous cell carcinoma. 9. Any other condition that, in the opinion of the Investigator, may lead to inappropriate participation in this study.
References
Publications (0)
Data not yet available
No reference posted for this study.