PRO1107 in Patients With Advanced Solid Tumors

Ovarian Cancer Clinical Trial

Official title:

A Phase 1/2 Study of PRO1107 in Patients With Advanced Solid Tumors

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06171789
• Other study ID #: PRO1107-001
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: January 29, 2024
• Est. completion date: February 2027

Study information

• Verified date: April 2024
• Source: ProfoundBio US Co.
• Contact: ProfoundBio Trial Support
• Phone: 1-844-774-4232
• Email: clinicaltrialinfo[@]profoundbio.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a global, open-label, multicenter Phase 1/2 study to evaluate the safety, tolerability, PK, and antitumor activity of PRO1107 in patients with advanced solid tumors. This study consists of 2 parts, Part A: dose escalation and dose level expansion, and Part B: tumor specific expansion.

Description:

This is a Phase 1/2 study of PRO1107, a PTK7 targeted antibody-drug conjugate, to evaluate the safety, tolerability, PK, and antitumor activity of PRO1107 in patients with advanced solid tumors, including ovarian cancer, endometrial cancer, triple negative breast cancer, non-small cell lung cancer, gastroesophageal cancer, and urothelial cancer. This study consists of 2 parts, Part A: Dose Escalation and Part B: Dose Expansion.

Part A may evaluate up to 7 dose levels of PRO1107 on Day 1 of a 21 day cycle by IV infusion.

Part B will be initiated at a dose level based on a comprehensive analysis of safety, tolerability, clinical PK, PD and activity data from Part A in up to 4 different cohorts of up to 40 patients per cohort.

Patients will continue to receive study treatment until the first instance of disease progression, unacceptable toxicity, investigator decision, consent withdrawal, study termination by the Sponsor, pregnancy, or death.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 214
• Est. completion date: February 2027
• Est. primary completion date: February 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria

• Pathologically confirmed diagnosis of one of the following tumor types:

• Ovarian cancer (epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer)

• Endometrial cancer (any subtype excluding sarcoma)

• Triple negative breast cancer (TNBC)

• Non-small cell lung cancer (NSCLC)

• Gastric or gastroesophageal junction (GEJ) adenocarcinoma

• Esophageal squamous cell carcinoma (ESCC)

• Urothelial cancers (bladder, ureter, or renal pelvis)

• Metastatic or unresectable locally advanced, recurrent, disease not amenable to further local therapy following prior systemic therapies known to confer clinical benefit. Measurable disease at baseline as defined per RECIST, Version 1.1 (Eisenhauer et al. 2009)

• Willing to provide a pre-treatment tumor specimen (archival or fresh biopsy samples).

• ECOG performance status score 0 or 1.

Exclusion Criteria

• Prior treatment with anti-PTK7 directed therapy.

• Had progressive disease as best response while on treatment with an auristatin (vedotin, pelidotin)-based antibody drug conjugate (ADC) as the most recent line of therapy.

• Other malignancy within 3 years

• Active CNS metastases (treated, stable CNS metastases are allowed)

• Uncontrolled infection within 2 weeks.

• Positive for HBV, HCV or HIV

• Use of a strong P450A CYP3A inhibitor within 2 weeks

• Additional protocol defined inclusion/exclusion criteria may apply

Related Conditions & MeSH terms

• Endometrial Cancer
• Endometrial Neoplasms
• GastroEsophageal Cancer
• Non-small Cell Lung Cancer
• Ovarian Cancer
• Triple Negative Breast Cancer
• Triple Negative Breast Neoplasms
• Urothelial Carcinoma

Intervention

Drug:
• PRO1107
Intravenous infusion of PRO1107

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	The University of Texas MD Anderson Cancer Center	Houston	Texas
United States	START Mountain Cancer Center	Salt Lake City	Utah
United States	HonorHealth Research Institute	Scottsdale	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
ProfoundBio US Co.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Immunogenic potential of PRO1107	Measure of anti-drug antibodies of PRO1107 in serum	Varying timepoints through end of treatment, up to approximately 1 year
Primary	Adverse Events	Type, incidence, severity, seriousness, and relatedness of adverse events	Through end of treatment, up to approximately 1 year
Primary	Laboratory abnormalities	Type, incidence, and severity of laboratory abnormalities	Through end of treatment, up to approximately 1 year
Primary	Dose limiting toxicity	Incidence of dose limiting toxicities	Through end of treatment, up to approximately 1 year
Secondary	Objective Response Rate	Patients who achieve partial or complete response per RECIST v1.1 criteria	Through end of treatment, up to approximately 1 year
Secondary	Disease Control Rate	Patients who achieve stable disease, partial or complete response per RECIST v1.1 criteria	Through end of treatment, up to approximately 1 year
Secondary	Progression-free survival	Time from start of treatment to first documented disease progression or death	Up to approximately 18 months
Secondary	Duration of objective response	Time from the first documentation of an objective tumor response (CR or PR) to the first documented tumor progression or death	From date of enrollment until the date of first documented disease progression or date of study withdrawal, whichever came first, assessed up to 12 months
Secondary	Pharmacokinetic parameter AUC for PRO1107	Measure of PRO1107 area under the concentration-time curve (AUC) in plasma.	Varying timepoints through end of treatment, up to approximately 1 year
Secondary	Pharmacokinetic parameter Cmax for PRO1107	Measure of the maximum concentration (Cmax) of PRO1107 in plasma.	Varying timepoints through end of treatment, up to approximately 1 year
Secondary	Pharmacokinetic parameter Tmax for PRO1107	Measure of the time to maximum concentration (Tmax) of PRO1107 in plasma.	Varying timepoints through end of treatment, up to approximately 1 year
Secondary	Pharmacokinetic parameter t1/2 for PRO1107	Measure of apparent terminal half-life (t1/2) of PRO1107 in plasma.	Varying timepoints through end of treatment, up to approximately 1 year
Secondary	Pharmacokinetic parameter Ctrough for PRO1107	Measure of the trough concentration (Ctrough) of PRO1107 in plasma.	Varying timepoints through end of treatment, up to approximately 1 year