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

Solid Tumor, Adult Clinical Trial

Official title:

A Phase 1B, Dose-Escalation Study of the Safety and Preliminary Efficacy of an Anti-Trop2 Antibody Drug Conjugate (STI-3258) in Patients With Relapsed or Refractory Solid Tumors

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05060276
• Other study ID #: T2ADC-RRST-101
• Status: Withdrawn
• Phase: Phase 1
• Start date: December 2022
• Est. completion date: December 2024

Study information

• Verified date: January 2023
• Source: Sorrento Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

This is a Phase 1b, open-label, dose-escalation study o STI-3258 administered intravenously in subjects with relapsed or refractory solid tumors including ovarian, breast, lung, esophageal, gastric, hepatocellular and urothelial cancers.

The study will determine any dose limiting toxicity (DLT), maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D), assessing safety and preliminary efficacy using ascending dose cohorts and a conventional 3+3 study design.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2024
• Est. primary completion date: May 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

• Has any significant medical condition, abnormality, or psychiatric illness that would prevent study participation.

Related Conditions & MeSH terms

• Neoplasms
• Refractory Cancer
• Relapsed Solid Neoplasm
• Solid Tumor, Adult

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sorrento Therapeutics, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Determine the MTD	Determine the MTD of STI-3258	Baseline through study completion at up to approximately 24 months
Primary	Determine the RP2D	To determine the RP2D of STI-3258	Baseline through study completion at up to approximately 24 months
Secondary	Assess preliminary efficacy of STI-3258	To assess the preliminary efficacy of STI-3258 in the treatment of patients with RRSTs based upon Response evaluation criteria in solid tumors (RECIST).	Baseline through study completion at up to approximately 24 months
Secondary	Assess the area under the curve (AUC) pharmacokinetic profile of STI-3258	To assess the AUC of STI-3258 in plasma as a measure of exposure to the ADC, STI-3258.	Baseline through study completion at up to approximately 24 months