General Information of This Antibody
Antibody ID
ANI0HGUAF
Antibody Name
STI-5171
Antibody Type
Monoclonal antibody (mAb)
Antibody Subtype
Humanized IgG
Antigen Name
ADP-ribosyl cyclase/cyclic ADP-ribose hydrolase 1 (CD38)
 Antigen Info 
Click to Show/Hide the Sequence Information of This Antibody
Each Antibody-drug Conjugate Related to This Antibody
Full Information of The Activity Data of The ADC(s) Related to This Antibody
STI-6129 [Phase 1/2]
Identified from the Human Clinical Data
Click To Hide/Show 10 Activity Data Related to This Level
Experiment 1 Reporting the Activity Date of This ADC [1]
Patients Enrolled
Patients with relapsed/refractory (RR) myeloma.
Administration Dosage
Dose range from 0.25 mg/kg to 3.68 mg/kg.
Related Clinical Trial
NCT Number NCT05565807  Clinical Status Phase 1/2
Clinical Description
A phase 1b/2a, open-label, dose-escalation and extension study to evaluate the safety and efficacy of an anti-CD38 antibody drug conjugate (STI-6129) in patients with relapsed or refractory multiple myeloma.
Experiment 2 Reporting the Activity Date of This ADC [2]
Related Clinical Trial
NCT Number NCT05308225  Clinical Status Phase 1/2
Clinical Description
A phase 1b/2a, open-label, dose-escalation study of the safety and efficacy of an anti-CD38 antibody drug conjugate (STI-6129) in patients with relapsed or refractory multiple myeloma.
Experiment 3 Reporting the Activity Date of This ADC [3]
Related Clinical Trial
NCT Number NCT04316442  Clinical Status Phase 1/2
Clinical Description
A phase 1b/2a, open-label, dose-escalation study of the safety and efficacy of an anti-CD38 antibody drug conjugate (STI-6129) in patients with relapsed or refractory systemic al amyloidosis.
Experiment 4 Reporting the Activity Date of This ADC [4]
Related Clinical Trial
NCT Number NCT05584709  Clinical Status Phase 1
Clinical Description
A phase 1b, open-label, dose-escalation study of the safety and efficacy of an anti-CD38 antibody drug conjugate (STI-6129) in patients with advanced solid tumors.
Experiment 5 Reporting the Activity Date of This ADC [5]
Related Clinical Trial
NCT Number NCT05519527  Clinical Status Phase 1
Clinical Description
A phase 1 study of safety and efficacy of an anti-CD38 antibody drug conjugate (STI-6129) in patients with relapsed or refractory t-acute lymphoblastic leukemia/lymphoma (T-ALL) or acute myeloid leukemia (AML).
Experiment 6 Reporting the Activity Date of This ADC [6]
Related Clinical Trial
NCT Number NCT05692908  Clinical Status Phase 1
Clinical Description
An open-label, dose-escalation study of the safety of an anti-CD38 antibody drug conjugate (STI-6129) in patients with relapsed or refractory systemic al amyloidosis.
Experiment 7 Reporting the Activity Date of This ADC [7]
Patients Enrolled
Eligibility requires: 1) Age ≥18 years with confirmed R/R T-ALL or AML (treatment-refractory to standard therapies); 2) ECOG 0-2; 3) Room air oxygen saturation ≥92%; 4) Protocol compliance commitment; 5) For reproductive-age patients: negative pregnancy test (females) and agreement to use dual contraception methods (both sexes) throughout study participation. Bone marrow confirmation of disease status is mandatory for enrollment.

   Click to Show/Hide
Administration Dosage
Participants of the first group will receive the lowest dose level. Participants of each new group will receive a higher dose than the group before it, if no intolerable side effects were seen. This will continue until the highest tolerable dose of STI-6129 is found.
Related Clinical Trial
NCT Number NCT05519527  Clinical Status PHASE1
Clinical Description
A Phase 1 Study of Safety and Efficacy of an Anti-CD38 Antibody Drug Conjugate (STI-6129) in Patients With Relapsed or Refractory T-Acute Lymphoblastic Leukemia/Lymphoma (T-ALL) or Acute Myeloid Leukemia (AML)
Primary Endpoint
Adverse event severity will be graded per NCI CTCAE v5.0 throughout the study duration (approximately 1 year). This standardized oncology toxicity scale will be applied to all reported adverse events to ensure consistent severity classification across all study participants.
Experiment 8 Reporting the Activity Date of This ADC [8]
Patients Enrolled
Key inclusion criteria: 1) Relapsed/refractory multiple myeloma (RRMM) refractory to proteasome inhibitors, immunomodulators, and anti-CD38 therapy; 2) Measurable disease by serum/M-protein, FLC assay, or ≥30% clonal plasma cells; 3) ECOG 0-2; 4) Room air oxygen saturation ≥92%; 5) Protocol compliance commitment; 6) Contraception adherence. All participants must have progressed after multiple prior lines of therapy.

   Click to Show/Hide
Administration Dosage
Seven dosing cohorts will be evaluated: 0.67 mg/kg, 0.88 mg/kg, 1.18 mg/kg, 1.56 mg/kg, 2.08 mg/kg, 2.77 mg/kg, 3.68 mg/kg where STI-6129 will be intravenously administered once as part of a 4-week treatment cycle
Related Clinical Trial
NCT Number NCT05308225  Clinical Status PHASE1|||PHASE2
Clinical Description
A Phase 1b/2a, Open-Label, Dose-Escalation Study of the Safety and Efficacy of an Anti-CD38 Antibody Drug Conjugate (STI-6129) in Patients With Relapsed or Refractory Multiple Myeloma
Primary Endpoint
Safety assessment of STI-6129 will be conducted from baseline through study completion (up to 24 months), evaluating incidence of adverse events (AEs), serious AEs (SAEs), dose-limiting toxicities (DLTs), neurotoxicity events, and laboratory abnormalities. All safety parameters will be graded according to NCI CTCAE v5.0 criteria.
Other Endpoint
Pharmacokinetic analysis will measure STI-6129 plasma concentrations (total antibody-conjugate and free toxin) throughout the 24-month study period. Efficacy evaluation includes overall response and duration per IMWG criteria, with preliminary activity assessed via overall response rate using modified IMWG response criteria.
Experiment 9 Reporting the Activity Date of This ADC [9]
Patients Enrolled
Key inclusion criteria require: 1) Age ≥18 with relapsed/refractory MM after ≥3 prior therapies (including PI, IMiD, and anti-CD38); 2) Measurable disease per IMWG criteria (serum M-protein ≥0.5g/dL, urine M-protein ≥200mg/24h, or abnormal FLC ≥10mg/dL); 3) ECOG 0-2; 4) Protocol compliance; 5) For reproductive-age patients: negative pregnancy test (females) and agreement to use highly effective contraception until 6 months post-treatment.

   Click to Show/Hide
Administration Dosage
Nine dosing cohorts will be evaluated: 0.25 mg/kg,0.50 mg/kg,0.67 mg/kg, 0.88 mg/kg, 1.18 mg/kg, 1.56 mg/kg, 2.08 mg/kg, 2.77 mg/kg, 3.68 mg/kg where STI-6129 will be intravenously administered once as part of a 4-week treatment cycle.
Related Clinical Trial
NCT Number NCT05565807  Clinical Status PHASE1|||PHASE2
Clinical Description
A Phase Ib/IIa, Open-Label, Dose-Escalation and Extension Study to Evaluate the Safety and Efficacy of An Anti-CD38 Antibody Drug Conjugate (STI-6129) in Patients With Relapsed or Refractory Multiple Myeloma
Primary Endpoint
Safety and efficacy assessments will be conducted over a 2-year period. Safety will be evaluated through incidence of adverse events (AEs) graded by CTCAE v5.0 criteria. Efficacy will be measured by overall response rate (ORR) using modified IMWG response criteria.
Other Endpoint
Pharmacokinetic analysis will quantify plasma concentrations of total anti-CD38 antibody, conjugated toxin (STI 6129), and free toxin (duostatin 5.2) over 2 years. Additional endpoints include: determination of RP2D in phase 1b; progression-free survival (PFS); overall survival (OS); time to first response (TTR); duration of response (DOR); and clinical benefit rate (CBR) - all assessed over the 2-year study duration.

   Click to Show/Hide
Experiment 10 Reporting the Activity Date of This ADC [10]
Patients Enrolled
Inclusion Criteria: Confirmed diagnosis of AL amyloidosis by tissue biopsy of an involved organ, or a surrogate site such as abdominal fat demonstrating amyloid deposition by mass spectrometry. The presence of a monoclonal light chain protein in serum. Relapsed or refractory AL amyloidosis is defined as patients who have received ≥ 2 lines of treatment. Patients must have received at least one proteasome inhibitor during their prior therapy. Patients who have received prior daratumumab treatment or prior stem cell transplantation remain eligible. Patients may have relapsed with disease progression or have been refractory to their last prior line of treatment. Progression of disease that develops > 60 days after the last dose of a treatment regimen in a patient who achieved at least a partial response (PR) defines a relapse. Refractory systemic AL amyloidosis is defined as the development of disease progression during therapy with an anti-AL amyloidosis treatment regimen or within 60 days of the last dose of an anti-AL amyloidosis treatment regimen or the achievement of less than a PR after ≥ 2 cycles. Measurable disease defined as the finding by serum-free light chain (FLC) assay that the difference between the involved and uninvolved FLC (dFLC) is ≥ 50 mg/L. Pulse oximetry ≥ 92% on room air. ECOG performance status of 0, 1, or 2. Willing to comply with the study schedule and all other protocol requirements. Females of childbearing potential (FCBP) must have 2 negative pregnancy tests prior to treatment. All heterosexually active FCBP and all heterosexually active male patients must agree to use effective methods of birth control throughout the study.

   Click to Show/Hide
Administration Dosage
Four cycles of intravenous infusion of STI-6129 will be given (one infusion every four weeks).
Related Clinical Trial
NCT Number NCT04316442  Clinical Status PHASE1|||PHASE2
Clinical Description
A Phase 1b/2a, Open-Label, Dose-Escalation Study of the Safety and Efficacy of an Anti-CD38 Antibody Drug Conjugate (STI-6129) in Patients With Relapsed or Refractory Systemic AL Amyloidosis
Primary Endpoint
Safety and tolerability of STI-6129 in AL amyloidosis patients [Time Frame: Baseline through study completion at up to 14 months] Types, frequencies, and severities of adverse events (AEs) and the relationships of AEs to study drug; includes serious adverse events (SAEs), neurotoxicity, dose-limiting toxicities (DLTs), and laboratory abnormalities.
Other Endpoint
Overall hematological response rate according to ISA consensus criteria [Time Frame: Every three weeks from day 1 to day 63, and bi-monthly for up to a year.] Complete Response (CR), Very Good Partial Response (VGPR), Partial Response (PR), Stable Disease (SD) and Progressive Disease (PD). Organ response rate according to ISA consensus criteria [Time Frame: Every three weeks from day 1 to day 63, and bi-monthly for up to a year.] Heart (by NT-proBNP or NYHA staging); Kidney (by creatinine and creatinine clearance and 24-hr urine protein), Liver (by serum alkaline phosphatase and liver size) and electromyogram for peripheral nerve system. Correlation of treatment response with disease severity based on the ISA 2012 consensus staging system [Time Frame: Every three weeks from day 1 to day 63, and bi-monthly for up to a year.] Disease staging is by how many hematologic and organ involvement criteria are exceeded. Determine plasma levels of STI-6129, total anti-CD38 antibody and Duostatin 5.2 [Time Frame: Day 1 to day 63] Measurement by ELISA and Mass Spectrophotometry Assays.

   Click to Show/Hide
References
Ref 1 First-in-human clinical trial of SC-006, a RNF43 targeted antibody-drug conjugate, as a monotherapy and in combination with budigalimab in patients with advanced colorectal cancer. Cancer Res (2020) 80 (16_Supplement): CT167.
Ref 2 A Phase 1b/2a, Open-Label, Dose-Escalation Study of the Safety and Efficacy of an Anti-CD38 Antibody Drug Conjugate (STI-6129) in Patients With Relapsed or Refractory Multiple Myeloma, NCT05308225
Ref 3 A Phase 1b/2a, Open-Label, Dose-Escalation Study of the Safety and Efficacy of an Anti-CD38 Antibody Drug Conjugate (STI-6129) in Patients With Relapsed or Refractory Systemic AL Amyloidosis, NCT04316442
Ref 4 A Phase 1B, Open-Label, Dose-Escalation Study of the Safety and Efficacy of an Anti-CD38 Antibody Drug Conjugate (STI-6129) in Patients With Advanced Solid Tumors, NCT05584709
Ref 5 A Phase 1 Study of Safety and Efficacy of an Anti-CD38 Antibody Drug Conjugate (STI-6129) in Patients With Relapsed or Refractory T-Acute Lymphoblastic Leukemia/Lymphoma (T-ALL) or Acute Myeloid Leukemia (AML), NCT05519527
Ref 6 An Open-Label, Dose-Escalation Study of the Safety of an Anti-CD38 Antibody Drug Conjugate (STI-6129) in Patients With Relapsed or Refractory Systemic AL Amyloidosis, NCT05692908
Ref 7 STI-6129 CD38 ADC for the Treatment of Patients With Relapsed or Refractory Systemic ALL Amyloidosis
Ref 8 Study to Assess Anti-CD38 Antibody Drug Conjugate in Relapsed or Refractory Multiple Myeloma
Ref 9 Safety and Efficacy Study of An Anti-CD38 Antibody Drug Conjugate in Relapsed or Refractory Multiple Myeloma
Ref 10 Study of the Safety and Efficacy of STI-6129 in Patients With Relapsed or Refractory Systemic AL Amyloidosis