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Advanced Solid TumorPhase 1/2NCT06480240

A Phase 1/2 Study of OBI-992 in Subjects With Advanced Solid Tumors

A Phase 1/2 study testing OBI-992 in people with Advanced Solid Tumor, run by OBI Pharma, Inc at 8 sites in 2 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This is a 2-part trial: Part A (Dose Escalation) is designed to establish the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of OBI-992 (Anti-TROP2 antibody drug conjugate, anti-TROP2 monoclonal antibody-cleavable peptide linker-exatecan) as monotherapy. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Solid Tumor
What is being tested?
OBI-992
Could I receive a placebo?
No, everyone receives an active treatment
How many people
117 participants
Where
8 sitesin 2 countries
Study dates
12 Jun 2024to Jun 2027
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or female subjects, 18 years of age or older at the time of consent
  • Provide written informed consent prior to performing any study-related procedure
  • Histologically or cytologically confirmed subjects with metastatic or advanced solid tumor that is not curable with local therapies
  • Subjects must have been treated with established standard-of-care therapy, or physicians have determined that such established therapy is not sufficiently efficacious, or subjects have declined to receive standard-of-care therapy. In the latter case, the informed consent must state the effective therapies the subject is declining.
  • Measurable disease (i.e., at least one measurable lesion per Response Evaluation Criteria in Solid Tumors version 1.1 [RECIST 1.1])
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
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  • Adequate organ function defined as:
  • Hepatic: i. Serum alanine aminotransferase (ALT) ≤3 × upper limit of normal (ULN), ≤5 × ULN in the presence of liver metastases ii. Serum aspartate aminotransferase (AST) ≤3 × ULN, ≤5 × ULN in presence of liver metastases iii. Serum bilirubin ≤1.5 × ULN (unless due to Gilbert's syndrome or hemolysis) b. Renal: i. Creatinine clearance >50 mL/minute using Cockcroft Gault equation c. Hematologic: i. Absolute neutrophil count ≥1,500/μL ii. Platelets ≥100,000/μL iii. Hemoglobin ≥8 g/dL
  • Subjects are willing and able to comply with all protocol-required assessments, visits, and procedures, including pretreatment tumor biopsy. Archival tumor biopsies are acceptable at baseline.
  • Females of childbearing potential must have negative serum pregnancy test prior to starting study therapy and agree to use a reliable form of contraceptive during the study treatment period and for at least 120 days following the last dose of study drug. Subject not of childbearing potential (i.e., permanently sterilized, postmenopausal) can be included in the trial. Postmenopausal is defined as 12 months with no menses without an alternative medical cause. Male subjects must agree to use an adequate method of contraception during the study treatment period and for at least 120 days following the last dose of study drug.
  • Cannot be breast feeding
  • Subjects with human immunodeficiency virus (HIV) infection are eligible if CD4+ Tcell counts ≥ 350 cells/μL; subjects on anti-retroviral therapy (ART) should be on an established dose for at least 4 weeks and have an HIV viral load less than 200 copies/mL prior to enrollment.
  • Subjects with serological evidence of chronic hepatitis B virus (HBV) infection are eligible if they have an HBV viral load below the limit of quantification with or without concurrent viral suppressive therapy.
  • Subjects with a history of hepatitis C virus (HCV) infection can be under curative antiviral treatment and have a viral load below the limit of quantification.
  • Subjects in Part B (Cohort-Expansion) - must have one of the following tumor types to be enrolled in the respective cohort:
  • Cohort 1: Non-small cell lung cancer (NSCLC)
  • o Pathologically confirmed subjects with metastatic NSCLC with or without actionable genomic alterations.
  • Cohort 2: Small cell lung cancer (SCLC)
  • Cohort 3: Gastric cancer

Who cannot join

  • Less than 3 weeks from prior cytotoxic chemotherapy or radiation therapy; and less than 5 half-lives or 3 weeks, whichever is shorter, from prior biologic therapies, prior to the first dose of OBI-992
  • Has undergone a major surgical procedure (as defined by the Investigator) or significant traumatic injury within 28 days prior to the first dose of OBI-992
  • Sensory or motor neuropathy of Grade 2 or greater
  • Subjects with a history of solid organ transplant
  • Unresolved toxicities from prior anticancer therapy, defined as having not resolved to Grade 0 or 1 (using National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE] version 5.0), except for alopecia and laboratory values listed in the inclusion criteria
  • Corrected QT interval (QTcF) prolongation to >470 msec based on the average of the screening 12-lead ECGs
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  • Known hypersensitivity to OBI-992 or its excipients
  • Has known untreated central nervous system (CNS) metastases. Subjects with treated brain metastases are eligible if there is no evidence of progression for at least 4 weeks after CNS-directed treatment, as ascertained by clinical examination and brain imaging (magnetic resonance imaging [MRI] or computed tomography [CT]) during the screening period
  • Has significant clinical cardiac abnormality (e.g., clinical heart failure or unstable angina)
  • Any medical comorbidity that is life-threatening or, in the opinion of the Investigator, renders the subject unsuitable for participation in a clinical trial due to possible noncompliance, would place the subject at an unacceptable risk (e.g. Interstitial lung disease (ILD)) and/or potential to affect interpretation of results of the study.
  • Subjects in Part B (Phase 2 Cohort Expansion) may not have had prior therapy with an approved or investigational TROP2 ADC (prior TROP2 ADC therapy allowed during dose escalation)
  • Is receiving any concurrent prohibited medications

Trial locations and contacts

8 sites in 2 countries.

8 sites in 2 countries

United States6 sites

  • Karmanos Cancer Institute

    Detroit, Michigan, 48201

  • NEXT Virginia

    Fairfax, Virginia, 22031

  • California Clinical Trials Medical Group (CCTMG)

    Glendale, California, 91206

  • The University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030

  • Scripps Green Hospital

    La Jolla, California, 92037

  • NEXT Oncology

    San Antonio, Texas, 78229

Other trials in United States

Taiwan2 sites

  • Taipei Tzu Chi Hospital

    New Taipei City, Xindian District, 231036

  • Taipei Medical University - Shuang Ho Hospital

    New Taipei City, Zhonghe District, 23561

Other trials in Taiwan

About this study

Official title: A Phase 1/2, Open-Label, Dose-Escalation and Cohort-Expansion Study Evaluating the Safety, Pharmacokinetics, and Therapeutic Activity of OBI-992 in Subjects With Advanced Solid Tumors

This is a 2-part trial: Part A (Dose Escalation) is designed to establish the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of OBI-992 (Anti-TROP2 antibody drug conjugate, anti-TROP2 monoclonal antibody-cleavable peptide linker-exatecan) as monotherapy. Part B (Cohort Expansion) is intended to further characterize the safety and preliminary clinical activity profile of the RP2D of OBI-992 in subjects with advanced solid tumors.

Being tested
OBI-992

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OBI-992Drug

    OBI-992 is an antibody-drug conjugate

Study groups in NCT06480240
Study groupRoleWhat they receive
Phase 1 Dose Escalation - Cohort 1ExperimentalOBI-992 at dose level 1 mg/kg, Q3W
Receives: Drug: OBI-992
Phase 1 Dose Escalation - Cohort 2ExperimentalOBI-992 at dose level 2 mg/kg, Q3W
Receives: Drug: OBI-992
Phase 1 Dose Escalation - Cohort 3ExperimentalOBI-992 at dose level 4 mg/kg, Q3W
Receives: Drug: OBI-992
Phase 1 Dose Escalation - Cohort 4ExperimentalOBI-992 at dose level 6 mg/kg, Q3W
Receives: Drug: OBI-992
Phase 1 Dose Escalation - Cohort 5ExperimentalOBI-992 at dose level 8 mg/kg, Q3W
Receives: Drug: OBI-992
Phase 1 Dose Escalation - Cohort 6ExperimentalOBI-992 at dose level 10 mg/kg, Q3W
Receives: Drug: OBI-992
Phase 2 Cohort Expansion - Cohort 1aExperimentalNon-small cell lung cancer indication cohort - Randomized dose optimization cohort. Dose level to be determined by the Safety Review Committee based on data available.
Receives: Drug: OBI-992
Phase 2 Cohort Expansion - Cohort 1bExperimentalNon-small cell lung cancer indication cohort - Randomized dose optimization cohort. Dose level to be determined by the Safety Review Committee based on data available.
Receives: Drug: OBI-992
Phase 2 Cohort Expansion - Cohort 2ExperimentalSmall cell lung cancer indication cohort - OBI-992 dosed at putative recommended phase 2 dose.
Receives: Drug: OBI-992
Phase 2 Cohort Expansion - Cohort 3ExperimentalGastric cancer indication cohort - OBI-992 dosed at putative recommended phase 2 dose.
Receives: Drug: OBI-992

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety and tolerability of OBI-992: incidence of adverse events, serious adverse events, and laboratory abnormalities

    To determine the safety and tolerability of OBI-992 when administered to subjects with advanced solid tumors, based on adverse events (AEs), serious adverse events (SAEs) and laboratory abnormalities graded by NCI CTCAE v5.0

    Measured: Duration of study, up to 2 years and 2 months

  2. Maximum tolerated dose and recommended Phase 2 dose of OBI-992

    To determine the maximum tolerated dose (MTD) and optimal recommended phase 2 dose (RP2D) of OBI-992

    Measured: Duration of study, up to 2 years and 2 months

  3. Preliminary clinical activity profile - objective response rate (ORR)

    Percentage of subjects in the as-treated population with objective response according to response evaluation criteria in solid tumors (RECIST v.1.1)

    Measured: Duration of study, up to 2 years and 2 months

  4. Preliminary clinical activity profile - clinical benefit rate (CBR)

    Percentage of subjects in the as-treated population with clinical benefit according to response evaluation criteria in solid tumors (RECIST v.1.1)

    Measured: Duration of study, up to 2 years and 2 months

  5. Preliminary clinical activity profile - duration of response (DOR)

    Percentage of subjects in the as-treated population with response according to response evaluation criteria in solid tumors (RECIST v.1.1)

    Measured: Duration of study, up to 2 years and 2 months

  6. Preliminary clinical activity profile - disease control rate (DCR)

    Percentage of subjects in the as-treated population with disease control according to response evaluation criteria in solid tumors (RECIST v.1.1)

    Measured: Duration of study, up to 2 years and 2 months

  7. Preliminary clinical activity profile - progression-free survival

    Percentage of subjects in the as-treated population with progression-free survival according to response evaluation criteria in solid tumors (RECIST v.1.1)

    Measured: Duration of study, up to 2 years and 2 months

Secondary outcomes (6)

  1. Immunogenicity of OBI-992: anti-drug antibodies (ADAs)

    To evaluate the immunogenicity of OBI-992 (anti-drug antibodies), characterized by percentage of subjects with ADAs in blood

    Measured: Duration of study, up to 2 years and 2 months

  2. Serum pharmacokinetics (PK): Peak Plasma Concentration (Cmax) of OBI-992 and its active metabolite

    To determine the serum Cmax of OBI-992 and its active metabolite exatecan

    Measured: Duration of study, up to 2 years and 2 months

  3. Serum pharmacokinetics (PK): area under the concentration-time curve (AUC) of OBI-992 and its active metabolite

    To determine the serum AUC of OBI-992 and its active metabolite exatecan

    Measured: Duration of study, up to 2 years and 2 months

  4. Serum pharmacokinetics (PK): half-life (T1/2) of OBI-992 and its active metabolite

    To determine the serum half-life of OBI-992 and its active metabolite exatecan

    Measured: Duration of study, up to 2 years and 2 months

  5. Serum pharmacokinetics (PK): clearance (CL) of OBI-992 and its active metabolite

    To determine the serum clearance (CL) of OBI-992 and its active metabolite exatecan

    Measured: Duration of study, up to 2 years and 2 months

  6. Serum pharmacokinetics (PK): Volume distribution at steady state (Vdss) of OBI-992 and its active metabolite

    To determine the serum volume distribution at steady state of OBI-992 and its active metabolite exatecan

    Measured: Duration of study, up to 2 years and 2 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jun 2024
  2. Study start12 Jun 2024
  3. Primary completionJun 2027 (estimated)
  4. Study completionJun 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Model description
Dose escalation: Interval (3+3) model Cohort expansion: parallel-group with randomized dosage optimization
Masking
None (open label)
Enrolment
117 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06480240
Sponsor's protocol ID
OBI-992-001
Status last verified
Aug 2025
First submitted
18 Jun 2024
Last updated
8 Aug 2025
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Shia CS, Wen SN, Hsu RY, Tu JS, Chang HW, Weng HC, Yang JJ, Chiang MF, Tsao YH, Lu CH, Chen YH, Wu YC, Chen YC, Li WF, Huang TY, Lai MT. Preclinical Pharmacokinetic, Pharmacodynamic, and Safety Profile of OBI-992: A Novel TROP2-Targeted Antibody-Drug Conjugate. Mol Cancer Ther. 2025 Dec 2;24(12):1938-1947. doi: 10.1158/1535-7163.MCT-24-1176.

    PubMed 40762235

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing OBI-992 in people with Advanced Solid Tumor, run by OBI Pharma, Inc at 8 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 19 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 8 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in United States, Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety and tolerability of OBI-992: incidence of adverse events, serious adverse events, and laboratory abnormalities (time frame: Duration of study, up to 2 years and 2 months). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06480240, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2025.

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