Study to Assess an Anti-Trop2 Antibody Drug Conjugate in Relapsed or Refractory Solid Tumors

NCT05060276 | Withdrawn Phase 1 FDA Drug

• 1 other identifier: T2ADC-RRST-101
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a phase 1b, open-label, dose-escalation study o STI-3258 administered intravenously in subjects with relapsed or refractory solid tumors.

Conditions

Relapsed Solid Neoplasm; Refractory Cancer; Solid Tumor, Adult

Keywords

relapsed or refractory solid tumors

Outcome Measures

Primary Outcomes (7)

• Incidence of adverse events by type, frequency, severity, and causality (safety)

  Safety as assessed by incidence of adverse events (AEs) by type, frequency, severity, and causality

  Baseline through study completion at up to approximately 24 months

• Incidence of treatment-emergent adverse events by type, frequency, severity, and causality (safety)

  Safety as assessed by incidence of treatment-emergent AEs (TEAEs) by type, frequency, severity, and causality

  Baseline through study completion at up to approximately 24 months

• Incidence of serious adverse events by type, frequency, severity, and causality (safety)

  Safety as assessed by incidence of serious AEs (SAEs) by type, frequency, severity, and causality

  Baseline through study completion at up to approximately 24 months

• Incidence of Infusion-related adverse events by type, frequency, severity, and causality (safety)

  Safety as assessed by incidence of Infusion-related AEs (IrAEs) by type, frequency, severity, and causality

  Baseline through study completion at up to approximately 24 months

• Incidence of dose-limiting toxicities (safety)

  Safety as assessed by incidence of dose-limiting toxicities

  Baseline through study completion at up to approximately 24 months

• Determine the MTD

  Determine the MTD of STI-3258

  Baseline through study completion at up to approximately 24 months

• Determine the RP2D

  To determine the RP2D of STI-3258

  Baseline through study completion at up to approximately 24 months

Secondary Outcomes (2)

• Assess preliminary efficacy of STI-3258

  Baseline through study completion at up to approximately 24 months

• Assess the area under the curve (AUC) pharmacokinetic profile of STI-3258

  Baseline through study completion at up to approximately 24 months

Study Arms (1)

STI-3258

EXPERIMENTAL

Intravenous infusion to be given with prophylaxis for infusion reactions, evaluating up to five dose cohorts including: 8 mg/kg, 12 mg/kg, 16 mg/kg, 20 mg/kg, and 24 mg/kg.

Biological: STI-3258

Interventions

STI-3258 BIOLOGICAL

Intravenous infusion of STI-3258 will be given (one infusion every three weeks).

Also known as: anti-Trop2-SN38 antibody drug conjugate (ADC)

STI-3258

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically or cytologically confirmed advanced cancer that is relapsing or refractory to at least one prior treatment and not a candidate for other treatments or is intolerant to established treatments.
• At least one measurable disease per Response Evaluation Criteria in Solid Tumors v. 1.1 (RECIST 1.1).
• Eastern Cooperative Oncology Group Performance Status ≤ 2.
• Must have a life expectancy of ≥ 6 months.
• Must have adequate bone marrow, hepatic and renal function as assessed by specific laboratory tests.
• Must be recovered ≤ Grade 1 from acute toxicities from previous therapies, excluding alopecia and vitiligo.
• Has not had prior treatment within 2 weeks of screening with high dose corticosteroids.
• Be willing and able to comply with the study schedule and all study requirements.
• Willing to follow all contraception guidelines.

You may not qualify if:

• Previous treatment with any systemic therapy or investigational drug within 2 weeks of the first dose of study drug.
• Currently participating in any other interventional clinical study.
• Has a diagnosis of other malignancies if the malignancy has required therapy within the last 3 years or is not in complete remission.
• Has presence of bulky disease defined as any mass \> 7 cm in greatest dimension will trigger a discussion with the medical monitor.
• Has left ventricular ejection fraction (LVEF) \< 40%.
• New York Heart Association (NYHA) Class ≥ 3.
• Has prolonged QTcF interval on an electrocardiogram.
• Has spinal cord compression or clinically active brain metastases.
• Has a history of Sacituzumab govitecan treatment.
• History of anaphylactic reaction to irinotecan or ≥ Grade 3 toxicity to prior irinotecan treatment.
• Has active or prior COVID-19 infection, with symptoms presenting within 4 weeks of the first dose of study drug.
• Has an active bacterial, viral, or fungal infection.
• Is currently pregnant or breast feeding or planning on either during the study.
• Has chronic or moderate chronic obstructive pulmonary disease or other chronic respiratory conditions unless receiving treatment and stable for 3 months prior to screening.
• Has known HIV or acquired immunodeficiency syndrome-related illness, acute or history of chronic hepatitis B or C.

Sponsors & Collaborators

• Sorrento Therapeutics, Inc.: lead

MeSH Terms

Conditions

Neoplasms; Recurrence

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Mike Royal, MD

  Sorrento Therapeutics, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: To determine DLT and MTD, the design uses a 3+3 ascending dose cohort design evaluating up to five dose cohorts including: 8 mg/kg, 12 mg/kg, 16 mg/kg, 20 mg/kg, 24 mg/kg.

Study Record Dates

• First Submitted: August 20, 2021
• First Posted: September 29, 2021
• Study Start: December 1, 2022
• Primary Completion: May 1, 2024
• Study Completion: December 1, 2024
• Last Updated: January 26, 2023

Record last verified: 2023-01