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

Brief Summary

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

Sponsor

Dren Bio

Recruitment Status

RECRUITING

Study Objective

TREATMENT

ClinicalTrials.gov ID

NCT06999187

Additional Identification number

Last Update Posted

2025-06-11

Study Completion (Actual)

2027-12

Study Record Versions

Contacts and Locations

facility: Dren Investigational Site
status: NOT_YET_RECRUITING
city: Denver
state: Colorado
zip: 80218
country: United States
contacts: [{name=Dren Bio Central Contact, role=CONTACT, phone=415-737-5277, email=clinops@drenbio.com}]
geoPoint: {lat=39.73915, lon=-104.9847}

facility: Dren Investigational Site
status: NOT_YET_RECRUITING
city: Orlando
state: Florida
zip: 32827
country: United States
contacts: [{name=Dren Bio Central Contact, role=CONTACT, phone=415-737-5277, email=clinops@drenbio.com}]
geoPoint: {lat=28.53834, lon=-81.37924}

facility: Dren Investigational Site
status: NOT_YET_RECRUITING
city: Sarasota
state: Florida
zip: 34232
country: United States
contacts: [{name=Dren Bio Central Contact, role=CONTACT, phone=415-737-5277, email=clinops@drenbio.com}]
geoPoint: {lat=27.33643, lon=-82.53065}

facility: Dren Investigational Site
status: RECRUITING
city: Huntersville
state: North Carolina
zip: 28078
country: United States
contacts: [{name=Dren Bio Central Contact, role=CONTACT, phone=415-737-5277, email=clinops@drenbio.com}]
geoPoint: {lat=35.41069, lon=-80.84285}

facility: Dren Investigational Site
status: NOT_YET_RECRUITING
city: Oklahoma City
state: Oklahoma
zip: 73104
country: United States
contacts: [{name=Dren Bio Central Contact, role=CONTACT, phone=415-737-5277, email=clinops@drenbio.com}]
geoPoint: {lat=35.46756, lon=-97.51643}

facility: Dren Investigational Site
status: NOT_YET_RECRUITING
city: Greenville
state: South Carolina
zip: 29605
country: United States
contacts: [{name=Dren Bio Central Contact, role=CONTACT, phone=415-737-5277, email=clinops@drenbio.com}]
geoPoint: {lat=34.85262, lon=-82.39401}

facility: Dren Investigational Site
status: RECRUITING
city: Austin
state: Texas
zip: 78758
country: United States
contacts: [{name=Dren Bio Central Contact, role=CONTACT, phone=415-737-5277, email=clinops@drenbio.com}]
geoPoint: {lat=30.26715, lon=-97.74306}

facility: Dren Investigational Site
status: NOT_YET_RECRUITING
city: Dallas
state: Texas
zip: 75230
country: United States
contacts: [{name=Dren Bio Central Contact, role=CONTACT, phone=415-737-5277, email=clinops@drenbio.com}]
geoPoint: {lat=32.78306, lon=-96.80667}

facility: Dren Investigational Site
status: RECRUITING
city: San Antonio
state: Texas
zip: 78229
country: United States
contacts: [{name=Dren Bio Central Contact, role=CONTACT, phone=415-737-5277, email=clinops@drenbio.com}]
geoPoint: {lat=29.42412, lon=-98.49363}

facility: Dren Investigational Site
status: RECRUITING
city: Fairfax
state: Virginia
zip: 22031
country: United States
contacts: [{name=Dren Bio Central Contact, role=CONTACT, phone=415-737-5277, email=clinops@drenbio.com}]
geoPoint: {lat=38.84622, lon=-77.30637}

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

TargetDisease

id: M5534
name: Carcinoma
asFound: Carcinoma
relevance: HIGH

id: M5220
name: Breast Neoplasms
asFound: Breast Cancer
relevance: HIGH

id: M11172
name: Lung Neoplasms
relevance: LOW

id: M5546
name: Carcinoma, Non-Small-Cell Lung
relevance: LOW

id: M14335
name: Prostatic Neoplasms
relevance: LOW

id: M30373
name: Triple Negative Breast Neoplasms
asFound: Triple Negative Breast Cancer
relevance: HIGH

id: M5830
name: Uterine Cervical Neoplasms
relevance: LOW

id: M3585
name: Adenocarcinoma
relevance: LOW

id: M5550
name: Carcinoma, Squamous Cell
relevance: LOW

id: M12974
name: Ovarian Neoplasms
relevance: LOW

id: M1704
name: Carcinoma, Ovarian Epithelial
relevance: LOW

id: M16064
name: Stomach Neoplasms
relevance: LOW

id: M5551
name: Carcinoma, Transitional Cell
relevance: LOW

id: M19235
name: Endometrial Neoplasms
asFound: Endometrial Cancer
relevance: HIGH

id: M1689
name: Squamous Cell Carcinoma of Head and Neck
asFound: Head and Neck Squamous Cell Carcinoma
relevance: HIGH

id: M12320
name: Neoplasms, Glandular and Epithelial
relevance: LOW

id: M12315
name: Neoplasms by Histologic Type
relevance: LOW

id: M5218
name: Breast Diseases
relevance: LOW

id: M15674
name: Skin Diseases
relevance: LOW

id: M17315
name: Urogenital Neoplasms
relevance: LOW

id: M2876
name: Genital Diseases
relevance: LOW

id: M2875
name: Urogenital Diseases
relevance: LOW

id: M8943
name: Genital Diseases, Female
relevance: LOW

id: M27093
name: Female Urogenital Diseases
relevance: LOW

id: M14127
name: Pregnancy Complications
relevance: LOW

id: M8399
name: Female Urogenital Diseases and Pregnancy Complications
relevance: LOW

id: M8945
name: Genital Neoplasms, Female
relevance: LOW

id: M17342
name: Uterine Neoplasms
relevance: LOW

id: M17339
name: Uterine Diseases
relevance: LOW

id: M9348
name: Head and Neck Neoplasms
relevance: LOW

id: T4352
name: Ovarian Cancer
asFound: Ovarian Cancer
relevance: HIGH

id: T4354
name: Ovarian Epithelial Cancer
relevance: LOW

id: T5486
name: Stomach Cancer
relevance: LOW

id: T5693
name: Transitional Cell Carcinoma
relevance: LOW

ProductName

IsActiveControl

IsControlDrug

IsPlacebo

ControlDrug

-

Intervention / Treatment

type: DRUG
name: DR-0202
description: DR-0202 is a bispecific antibody
armGroupLabels: [DL1 of DR-0202, DL2 of DR-0202, DL3 of DR-0202, DL4 of DR-0202, DL5 of DR-0202, DL6 of DR-0202, DL7 of DR-0202, DL8 of DR-0202]

Intervention

Study Type

INTERVENTIONAL

Phase

PHASE1

Allocation

NON_RANDOMIZED

Interventional Model

SEQUENTIAL

Subject Blind

Arm Label

Arm Type

label: DL1 of DR-0202
type: EXPERIMENTAL
description: Participants in this arm will receive DL1 milligrams of DR-0202 every 2 weeks until progression or withdrawal
interventionNames: [Drug: DR-0202]

label: DL2 of DR-0202
type: EXPERIMENTAL
description: Participants in this arm will receive DL2 milligrams of DR-0202 every 2 weeks until progression or withdrawal
interventionNames: [Drug: DR-0202]

label: DL3 of DR-0202
type: EXPERIMENTAL
description: Participants in this arm will receive DL3 milligrams of DR-0202 every 2 weeks until progression or withdrawal
interventionNames: [Drug: DR-0202]

label: DL4 of DR-0202
type: EXPERIMENTAL
description: Participants in this arm will receive DL4 milligrams of DR-0202 every 2 weeks until progression or withdrawal
interventionNames: [Drug: DR-0202]

label: DL5 of DR-0202
type: EXPERIMENTAL
description: Participants in this arm will receive DL5 milligrams of DR-0202 every 2 weeks until progression or withdrawal
interventionNames: [Drug: DR-0202]

label: DL6 of DR-0202
type: EXPERIMENTAL
description: Participants in this arm will receive DL6 milligrams of DR-0202 every 2 weeks until progression or withdrawal
interventionNames: [Drug: DR-0202]

label: DL7 of DR-0202
type: EXPERIMENTAL
description: Participants in this arm will receive DL7 milligrams of DR-0202 every 2 weeks until progression or withdrawal
interventionNames: [Drug: DR-0202]

label: DL8 of DR-0202
type: EXPERIMENTAL
description: Participants in this arm will receive DL8 milligrams of DR-0202 every 2 weeks until progression or withdrawal
interventionNames: [Drug: DR-0202]

NumberOfInterventionGroups

0

GroupEnrollment

Target Number of Participant

0

InstitutionLocation

InstitutionPhoneNumber

Study Site

Location Countries

Countries of recruitment

Study Start (Actual)

2025-06-03

Arm Description

Inclusion and Exclusion Criteria

Inclusion 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 Exclusion Criteria: * 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. Note: Treatment with systemic corticosteroids ≤ 25 mg/day (prednisone or equivalent) and inhaled or topical steroids are allowed. For participants with CRPC, LHRH agents are allowed. * 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.

minimum age

18 Years

maximum age

Standard ages

ADULT

OLDER_ADULT

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

NO

Enrollment (Actual)

96

Original Enrollment (Actual)

0

Final Enrollment Number

0

FinalSubjectSelectionDate

AnalysisTargetGroup

DemographicInformation

Primary Outcome Measures

measure: Incidence, severity, and relationship of treatment-emergent adverse events (TEAEs) as assessed by CTCAE v5.0 during DR-0202 treatment through study completion (Safety and Tolerability)
description: * Incidence, severity, and relationship of TEAEs (per CTCAE v5.0) through study completion (expected to be an average of 1 year) including but not limited to vital signs, clinical laboratory values (hematology, clinical chemistry, coagulation, urinalysis), 12-lead ECG * Occurrence of DLTs during Cycle 1 (28 days)
timeFrame: 28-day DLT Period and Treatment Duration / Study Completion

Secondary Outcome Measures

PrimaryEndpointResult

Primary Completion Date (Actual)

2027-07

ClinicalTrialResultSummary

Telephone

Address

Name

Title

Telephone

name: Dren Bio Central Contact
role: CONTACT
phone: 415-737-5277
email: clinops@drenbio.com

Affiliation