OBI-902 for Cancer

Recruiting at 5 trial locations

Overseen By OBI Pharma, Inc. Sponsor

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: OBI Pharma, Inc

Must not be taking: TROP2 therapies

Disqualifiers: Organ transplant, Neuropathy, Cardiac abnormality, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

111 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests OBI-902, a new treatment for various advanced or metastatic solid tumors. The goal is to determine the best dose and assess its safety and effectiveness. In the first part, researchers test different doses to identify the safest and most effective one. The second part examines how well the treatment works in specific cancers, such as breast cancer, endometrial cancer, and cholangiocarcinoma. Individuals with advanced cancers that do not respond to standard treatments or who have opted not to pursue them might be suitable for this trial. As a Phase 1/Phase 2 trial, this research aims to understand how the treatment works in people and measure its effectiveness in an initial, smaller group, offering participants a chance to be among the first to benefit from this new therapy.

Do I have to stop taking my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. However, you cannot participate if you are taking any medications that are specifically prohibited by the trial protocol.

Is there any evidence suggesting that OBI-902 is likely to be safe for humans?

Research has shown that OBI-902, a new cancer treatment, demonstrates promising safety features in early studies. In both lab and animal studies, it behaved consistently and was well-tolerated, meaning it remained stable and effective in the body. The treatment is an antibody-drug conjugate (ADC), which links a drug to an antibody. This design helps target cancer cells directly, minimizing harm to healthy cells. Although this information is encouraging, the testing process is still in its early stages. The trial aims to confirm these findings in humans and determine safe dosage levels. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about OBI-902 because it offers a new approach to treating cancer by targeting and inhibiting specific proteins crucial for tumor growth. Unlike standard chemotherapies, which attack all rapidly dividing cells, OBI-902 works more selectively, potentially leading to fewer side effects. Additionally, this treatment is being explored at various dosage levels and in different cancer types, such as HER2-negative breast cancer and endometrial carcinoma, to optimize its effectiveness and broaden its application. With its unique mechanism of action and targeted approach, OBI-902 holds promise for improved outcomes in challenging cancer cases.

What evidence suggests that OBI-902 might be an effective treatment for cancer?

Research has shown that OBI-902, which participants in this trial may receive, could effectively treat various advanced solid tumors. Studies in lab models have demonstrated strong anti-tumor effects in cancers such as lung, pancreatic, stomach, and colorectal. OBI-902 targets a protein called TROP2, often found in high amounts in many cancers. Early tests suggested that it works better and is absorbed more effectively than similar treatments. These promising results offer hope for potential benefits for patients with different types of advanced cancers. ^{1 3 6 7 8}

Are You a Good Fit for This Trial?

This trial is for individuals with advanced solid tumors. Specific eligibility criteria are not provided, but typically participants must have a measurable disease, adequate organ function, and no prior adverse reactions to similar treatments.

Inclusion Criteria

Measurable disease (i.e., at least one measurable lesion per RECIST 1.1)

Cannot be breast feeding.

I have chronic HBV but my viral load is undetectable, with or without treatment.

Exclusion Criteria

I do not have serious heart problems like heart failure or unstable chest pain.

I haven't had chemotherapy, radiation, or biologic therapy recently.

Corrected QT interval (QTcF) prolongation to >470 msec based on the average of the screening 12-lead ECGs

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Part A of the trial to establish the maximum tolerated dose (MTD) and putative recommended phase 2 dose of OBI-902 as monotherapy

Up to 54 weeks

Cohort Expansion

Part B of the trial to determine the optimal RP2D and further characterize the safety and preliminary clinical activity profile of the OBI-902 RP2D

Up to 54 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

52 weeks

What Are the Treatments Tested in This Trial?

Interventions

• OBI-902

Trial Overview The study is testing OBI-902 in two parts: Part A seeks the highest dose patients can tolerate without severe side effects (MTD), and Part B expands the cohort at this dose to assess safety and early signs of effectiveness.

How Is the Trial Designed?

Group I: Phase 2 Cohort Expansion: Cohort 3 Experimental Treatment 1 Intervention

OBI-902 at putative RP2D; Intra- and extrahepatic cholangiocarcinoma cohort

Group II: Phase 2 Cohort Expansion: Cohort 2 Experimental Treatment 1 Intervention

OBI-902 at putative RP2D; relapsed/refractory Endometrial carcinoma cohort

Group III: Phase 2 Cohort Expansion: Cohort 1B Experimental Treatment 1 Intervention

A randomized dosage optimization cohort for relapsed/refractory HER2-negative breast cancer participants

Group IV: Phase 2 Cohort Expansion: Cohort 1A Experimental Treatment 1 Intervention

A randomized dosage optimization cohort for relapsed/refractory HER2-negative breast cancer participants

Group V: Phase 1 Dose Escalation: Cohort 6 Experimental Treatment 1 Intervention

OBI-902 at dose level 10.0 mg/kg, Q3W

Group VI: Phase 1 Dose Escalation: Cohort 5 Experimental Treatment 1 Intervention

OBI-902 at dose level 8.0 mg/kg, Q3W

Group VII: Phase 1 Dose Escalation: Cohort 4 Experimental Treatment 1 Intervention

OBI-902 at dose level 6.0 mg/kg, Q3W

Group VIII: Phase 1 Dose Escalation: Cohort 3 Experimental Treatment 1 Intervention

OBI-902 at dose level 4.5 mg/kg, Q3W

Group IX: Phase 1 Dose Escalation: Cohort 2 Experimental Treatment 1 Intervention

OBI-902 at dose level 3.0 mg/kg, Q3W

Group X: Phase 1 Dose Escalation: Cohort 1 Experimental Treatment 1 Intervention

OBI-902 at dose level 1.6 mg/kg, Q3W

Who Is Running the Clinical Trial?

OBI Pharma, Inc

Lead Sponsor

Trials

9

Recruited

1,500+

Citations

1. targetedonc.com targetedonc.com/view/fda-clears-ind-of-obi-902-trop-2-adc-for-advanced-solid-tumors

FDA Clears IND of OBI-902, Trop-2 ADC for Advanced ... One study evaluated OBI-902 in xenograft models of non–small cell lung cancer, pancreatic cancer, gastric cancer, and colorectal cancer, where ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT07124117

NCT07124117 | A Study Evaluating OBI-902 in Participants ... This is a 2-part trial: Part A (Dose Escalation) is designed to establish the maximum tolerated dose (MTD) and putative recommended phase 2 dose of OBI-902 ...

3. obipharma.com obipharma.com/news/obi-pharma-announces-phase-1-2-study-initiation-for-obi-902/

OBI Pharma Announces Phase 1/2 Study Initiation for OBI-902, a ... OBI-902 is the first ADC utilizing OBI's proprietary GlycOBI® ADC enabling technology for evaluation of safety and efficacy in Cancer.

4. trial.medpath.com trial.medpath.com/news/8fc2a57249da1162/obi-pharma-initiates-phase-1-2-trial-for-novel-trop2-targeted-adc-obi-902-in-advanced-solid-tumors

OBI Pharma Initiates Phase 1/2 Trial for Novel TROP2-Targeted ... OBI-902 demonstrated superior antitumor activities and favorable pharmacokinetics compared to other TROP2 ADCs in preclinical studies presented at AACR 2025.

5. clinicaltrialvanguard.com clinicaltrialvanguard.com/news/obi-pharma-announces-fda-ind-clearance-for-phase-1-2-study-of-obi-902-a-trop-2-targeting-adc/

OBI Pharma Announces FDA IND Clearance for Phase 1/2 ... Data presented at the 2025 American Association for Cancer Research (AACR) meeting demonstrated enhanced linker-payload stability, favorable ...

6. obipharma.com obipharma.com/news/obi-pharma-announces-u-s-fda-clearance-of-ind-application-for-a-phase-1-2-study-of-obi-902/

OBI Pharma Announces U.S. FDA Clearance of IND ... OBI-902 is a Trop-2-targeted antibody-drug conjugate (ADC) that carries a potent topoisomerase I inhibitor payload to kill tumor cells and with a drug-antibody ...

7. aacrjournals.org aacrjournals.org/cancerres/article/85/8_Supplement_1/4356/757617/Abstract-4356-OBI-902-a-novel-TROP2-targeted

Abstract 4356: OBI-902, a novel TROP2 targeted antibody ... OBI-902, a novel TROP2 targeted antibody-drug conjugate via GlycOBI platform, has favorable pharmacokinetics and sustained antitumor activities ...

8. firstwordpharma.com firstwordpharma.com/story/5994014

OBI Pharma Announces Phase 1/2 Study Initiation for OBI ... OBI plans to enroll patients with advanced solid tumors with the objective of verifying the safety, pharmacokinetics, and preliminary efficacy ...