RECRUITING

A Study of DR-0202 in Patients With Locally Advanced or Metastatic, Relapsed or Refractory Carcinomas

Conditions

Triple Negative Breast Cancer HER2-negative Breast Cancer Non Small Cell Lung Cancer Cervical Cancer Castrate Resistant Prostate Cancer Pancreatic Ductal Adenocarcinoma Head-and-neck Squamous Cell Carcinoma Endometrial Cancer Ovarian Cancer Gastric Cancer Gastroesophageal-junction Cancer Urothelial Carcinoma

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

A phase 1a/1b, multicenter, open-label, dose escalation/expansion, multiple-dose study to evaluate the safety and activity of DR-0202 in patients with locally advanced or metastatic, relapsed or refractory carcinomas

Official Title

A Phase 1a/1b, Multicenter, Open-label, Dose Escalation/Expansion, Multiple-dose Study to Evaluate the Safety and Activity of DR-0202 in Patients With Locally Advanced or Metastatic, Relapsed or Refractory Carcinomas

Quick Facts

Study Start:2025-06

Study Completion:2027-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06999187

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Histologically confirmed epithelial cancer of the following tumor types: breast (TNBC, HR+/HER2-/+BC), NSCLC, cervical, CRPC, PDAC, HNSCC, endometrial, ovarian, gastric/GEJ, or urothelial that is unresectable, locally advanced or metastatic * Relapsed or refractory with at least 2 prior lines of therapy and for which no standard of care treatment options are available * Radiographically measurable disease * Eastern Cooperative Oncology Group (ECOG) performance status 0-1 * Life expectancy, in the opinion of the Investigator, of ≥ 3 months * Adequate marrow reserve, renal function, and hepatic function * Taper of ≥ 2 weeks from high-dose systemic corticosteroids (however, low dose corticosteroids ≤ 25 mg prednisone or equivalent daily are permitted in consultation with the Medical Monitor) * Willing to provide archival tumor tissue samples or agree to a baseline biopsy if not available * Willing to undergo an on-treatment biopsy if clinically feasible and not contraindicated at the time of procedure	* Major surgery within 28 days prior to Day 1 * Have not had an appropriate washout period from systemic therapy, including investigational agents, prior to C1D1: 1. Systemic chemotherapy and anticancer therapies within 4 weeks or 5 half-lives of the drug, whichever is shorter. 2. Antibody-based anticancer therapy: ≥ 4 weeks. 3. Prior Trop-2-directed therapy within 5 half-lives of the drug. * Radiation therapy within 21 days prior to C1D1. Palliative radiation therapy may be allowed following discussion with Medical Monitor * Brain metastases either untreated and symptomatic or requiring therapy with steroids or anticonvulsants to control associated symptoms. Brain metastases that have been treated and are no longer symptomatic are allowed if use of high-dose systemic corticosteroids (\> 25 mg/day of prednisone or equivalent) is stopped ≥ 12 weeks prior to C1D1. * Active Grade ≥ 2 anorexia, nausea or vomiting, and/or signs of intestinal obstruction. * Another malignancy (except for adequately resected non-melanoma skin cancer, curatively treated in situ disease, or other solid tumors curatively treated with no evidence of disease for ≥ 1 year) * Evidence of significant, uncontrolled concomitant disease that could affect compliance with study. * Current or past history of CNS disease, such as stroke, epilepsy, central nervous system vasculitis or neurodegenerative disease (participants with a history of stroke who have not experienced a stroke or transient ischemic attack in the past 6 months and have no residual neurologic deficits may be eligible). * QT interval for heart rate using Fridericia's formula (QTcF) \> 480 msec or history of additional risk factors for Torsades de Pointes * Uncontrolled or significant cardiovascular disease * History or presence of an abnormal ECG that is clinically significant in the Investigator's opinion or myocardial infarction within 6 months prior to C1D1. * Prior solid organ transplantation. * Known infection with HIV, HBV, or HCV. The following participants may be enrolled in this study (the Sponsor reserves the right to restrict enrollment of these participants): 1. Participants who are HIV-positive with undetectable HIV RNA and at least 3 months on antiretroviral therapy. 2. Participants with a positive serologic test for HBV (i.e., positive HBcAb and negative HBsAg) and have a negative PCR test. 3. Participants who are HCV-positive who have completed at least 1 month of highly effective antiviral therapy and have a negative PCR test. * Active infection requiring systemic treatment, defined as requiring IV antimicrobial, antifungal, or antiviral agents within 2 weeks prior to C1D1. Prophylactic antimicrobial treatment is allowed. Infections eligible per Exclusion Criterion 16 may be enrolled. * Active clinical interstitial pneumonitis (e.g., shortness of breath, requirement of supplemental oxygen, dry cough) or as confirmed by means of diagnostic imaging within 6 months prior to C1D1. * Other concurrent medical or psychiatric conditions that, in the Investigator's opinion, may be likely to confound study interpretation or prevent completion of study procedures and follow-up examinations.

Inclusion Criteria

Exclusion Criteria

* Histologically confirmed epithelial cancer of the following tumor types: breast (TNBC, HR+/HER2-/+BC), NSCLC, cervical, CRPC, PDAC, HNSCC, endometrial, ovarian, gastric/GEJ, or urothelial that is unresectable, locally advanced or metastatic
* Relapsed or refractory with at least 2 prior lines of therapy and for which no standard of care treatment options are available
* Radiographically measurable disease
* Eastern Cooperative Oncology Group (ECOG) performance status 0-1
* Life expectancy, in the opinion of the Investigator, of ≥ 3 months
* Adequate marrow reserve, renal function, and hepatic function
* Taper of ≥ 2 weeks from high-dose systemic corticosteroids (however, low dose corticosteroids ≤ 25 mg prednisone or equivalent daily are permitted in consultation with the Medical Monitor)
* Willing to provide archival tumor tissue samples or agree to a baseline biopsy if not available
* Willing to undergo an on-treatment biopsy if clinically feasible and not contraindicated at the time of procedure

* Major surgery within 28 days prior to Day 1
* Have not had an appropriate washout period from systemic therapy, including investigational agents, prior to C1D1:
1. Systemic chemotherapy and anticancer therapies within 4 weeks or 5 half-lives of the drug, whichever is shorter.
2. Antibody-based anticancer therapy: ≥ 4 weeks.
3. Prior Trop-2-directed therapy within 5 half-lives of the drug.
* Radiation therapy within 21 days prior to C1D1. Palliative radiation therapy may be allowed following discussion with Medical Monitor
* Brain metastases either untreated and symptomatic or requiring therapy with steroids or anticonvulsants to control associated symptoms. Brain metastases that have been treated and are no longer symptomatic are allowed if use of high-dose systemic corticosteroids (\> 25 mg/day of prednisone or equivalent) is stopped ≥ 12 weeks prior to C1D1.
* Active Grade ≥ 2 anorexia, nausea or vomiting, and/or signs of intestinal obstruction.
* Another malignancy (except for adequately resected non-melanoma skin cancer, curatively treated in situ disease, or other solid tumors curatively treated with no evidence of disease for ≥ 1 year)
* Evidence of significant, uncontrolled concomitant disease that could affect compliance with study.
* Current or past history of CNS disease, such as stroke, epilepsy, central nervous system vasculitis or neurodegenerative disease (participants with a history of stroke who have not experienced a stroke or transient ischemic attack in the past 6 months and have no residual neurologic deficits may be eligible).
* QT interval for heart rate using Fridericia's formula (QTcF) \> 480 msec or history of additional risk factors for Torsades de Pointes
* Uncontrolled or significant cardiovascular disease
* History or presence of an abnormal ECG that is clinically significant in the Investigator's opinion or myocardial infarction within 6 months prior to C1D1.
* Prior solid organ transplantation.
* Known infection with HIV, HBV, or HCV. The following participants may be enrolled in this study (the Sponsor reserves the right to restrict enrollment of these participants):
1. Participants who are HIV-positive with undetectable HIV RNA and at least 3 months on antiretroviral therapy.
2. Participants with a positive serologic test for HBV (i.e., positive HBcAb and negative HBsAg) and have a negative PCR test.
3. Participants who are HCV-positive who have completed at least 1 month of highly effective antiviral therapy and have a negative PCR test.
* Active infection requiring systemic treatment, defined as requiring IV antimicrobial, antifungal, or antiviral agents within 2 weeks prior to C1D1. Prophylactic antimicrobial treatment is allowed. Infections eligible per Exclusion Criterion 16 may be enrolled.
* Active clinical interstitial pneumonitis (e.g., shortness of breath, requirement of supplemental oxygen, dry cough) or as confirmed by means of diagnostic imaging within 6 months prior to C1D1.
* Other concurrent medical or psychiatric conditions that, in the Investigator's opinion, may be likely to confound study interpretation or prevent completion of study procedures and follow-up examinations.

Contacts and Locations

Study Contact

Dren Bio Central Contact

CONTACT

415-737-5277

clinops@drenbio.com

Principal Investigator

Wan Jen Hong, MD

STUDY_DIRECTOR

Dren Bio

Study Locations (Sites)

Dren Investigational Site

Fairfax, Virginia, 22031

United States

Collaborators and Investigators

Sponsor: Dren Bio

Wan Jen Hong, MD, STUDY_DIRECTOR, Dren Bio

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-06

Study Completion Date2027-12

Study Record Updates

Study Start Date2025-06

Study Completion Date2027-12

Terms related to this study

Additional Relevant MeSH Terms

Triple Negative Breast Cancer
HER2-negative Breast Cancer
Non Small Cell Lung Cancer
Cervical Cancer
Castrate Resistant Prostate Cancer
Pancreatic Ductal Adenocarcinoma
Head-and-neck Squamous Cell Carcinoma
Endometrial Cancer
Ovarian Cancer
Gastric Cancer
Gastroesophageal-junction Cancer
Urothelial Carcinoma