Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06171789
Other study ID # PRO1107-001
Secondary ID
Status Recruiting
Phase Phase 1/Phase 2
First received
Last updated
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
Health authority
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

Study Design


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
See also
  Status Clinical Trial Phase
Completed NCT02526017 - Study of Cabiralizumab in Combination With Nivolumab in Patients With Selected Advanced Cancers Phase 1
Withdrawn NCT05201001 - APX005M in Patients With Recurrent Ovarian Cancer Phase 2
Completed NCT02963831 - A Study to Investigate ONCOS-102 in Combination With Durvalumab in Subjects With Advanced Peritoneal Malignancies Phase 1/Phase 2
Not yet recruiting NCT06376253 - A Phase I Study of [177Lu]Lu-EVS459 in Patients With Ovarian and Lung Cancers Phase 1
Recruiting NCT05489211 - Study of Dato-Dxd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03) Phase 2
Recruiting NCT03412877 - Administration of Autologous T-Cells Genetically Engineered to Express T-Cell Receptors Reactive Against Neoantigens in People With Metastatic Cancer Phase 2
Active, not recruiting NCT03667716 - COM701 (an Inhibitor of PVRIG) in Subjects With Advanced Solid Tumors. Phase 1
Active, not recruiting NCT03170960 - Study of Cabozantinib in Combination With Atezolizumab to Subjects With Locally Advanced or Metastatic Solid Tumors Phase 1/Phase 2
Recruiting NCT05156892 - Tamoxifen and SUBA-Itraconzole Combination Testing in Ovarian Cancer Phase 1
Suspended NCT02432378 - Intensive Locoregional Chemoimmunotherapy for Recurrent Ovarian Cancer Plus Intranodal DC Vaccines Phase 1/Phase 2
Recruiting NCT04533763 - Living WELL: A Web-Based Program for Ovarian Cancer Survivors N/A
Active, not recruiting NCT03371693 - Cytoreductive Surgery(CRS) Plus Hyperthermic Intraperitoneal Chemotherapy(HIPEC) With Lobaplatin in Advanced and Recurrent Epithelial Ovarian Cancer Phase 3
Withdrawn NCT03032614 - Combination of Carboplatin, Eribulin and Veliparib in Stage IV Cancer Patients Phase 2
Completed NCT01936363 - Trial of Pimasertib With SAR245409 or Placebo in Ovarian Cancer Phase 2
Completed NCT02019524 - Phase Ib Trial of Two Folate Binding Protein Peptide Vaccines (E39 and J65) in Breast and Ovarian Cancer Patients Phase 1
Terminated NCT00788125 - Dasatinib, Ifosfamide, Carboplatin, and Etoposide in Treating Young Patients With Metastatic or Recurrent Malignant Solid Tumors Phase 1/Phase 2
Active, not recruiting NCT05059522 - Continued Access Study for Participants Deriving Benefit in Pfizer-Sponsored Avelumab Parent Studies That Are Closing Phase 3
Active, not recruiting NCT04383210 - Study of Seribantumab in Adult Patients With NRG1 Gene Fusion Positive Advanced Solid Tumors Phase 2
Terminated NCT04586335 - Study of CYH33 in Combination With Olaparib an Oral PARP Inhibitor in Patients With Advanced Solid Tumors. Phase 1
Terminated NCT03146663 - NUC-1031 in Patients With Platinum-Resistant Ovarian Cancer Phase 2