Locally Advanced Solid TumorPhase 1/2NCT04084366

Phase 1/2 Study of OBI-999 in Patients With Advanced Solid Tumors

A Phase 1/2 study testing OBI-999 in people with Locally Advanced Solid Tumor, run by OBI Pharma, Inc at 4 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

The purpose of this study is to establish the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of OBI-999 as monotherapy, and to characterize the safety and preliminary clinical activity profile of the RP2D of OBI-999 in patients with advanced solid tumors. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Locally Advanced Solid Tumor
What is being tested?: OBI-999
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 44 participants
Where: 4 sitesUnited States
Study dates: 25 Nov 2019to 27 Oct 2023
Phase: Phase 1/2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 patients, 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 patients with advanced solid tumors.
Patients must have been treated with established standard-of-care therapy, or physicians have determined that such established therapy is not sufficiently efficacious, or patients have declined to receive standard-of-care therapy. In the latter case, the informed consent must state the effective therapies the patient is declining.
Measurable disease (i.e., at least one measurable lesion per RECIST 1.1)
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

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Adequate organ function defined as:
Hepatic:
Serum ALT ≤3 × upper limit of normal (ULN), ≤5 × ULN in the presence of liver metastases
Serum AST ≤3 × ULN, ≤5 × ULN in presence of liver metastases
iii.Serum bilirubin ≤1.5 × ULN (unless due to Gilbert's syndrome or hemolysis)
Renal:
Creatinine clearance >50 mL/minute using Cockcroft Gault equation
Hematologic:
Absolute neutrophil count ≥1,500/µL
Platelets ≥100,000/µL
Hemoglobin ≥8 g/dL
Patient is willing and able to comply with all protocol required assessments, visits, and procedures, including a 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.
Patient not of childbearing potential (i.e., permanently sterilized, postmenopausal) can be included in study. Postmenopausal is defined as 12 months with no menses without an alternative medical cause.
Male patients 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.
Patients with human immunodeficiency virus (HIV) infection are eligible if CD4+ T cell counts ≥ 350 cells/uL; patients on antiretroviral therapy (ART) should be on an established dose for at least 4 weeks and have an HIV viral load less than 400 copies/mL prior to enrollment.
Patients 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.
Patients with a history of hepatitis C virus (HCV) infection should have completed curative antiviral treatment and have a viral load below the limit of quantification.
Patients in Part B (Cohort-Expansion) must have documented Globo H H score of at least 100 from a qualified laboratory IHC assay in one of the sponsor-selected tumor types to be enrolled in the respective cohort:
Cohort 1: Pancreatic cancer
Cohort 2: Esophageal cancer
Cohort 3: Gastric cancer
Cohort 4: Colorectal cancer
Cohort 5: Basket (any solid tumor type other than those included in Cohorts 1 through 4).

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 999.
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 999.
Sensory or motor neuropathy of Grade 2 or greater.
Patients with a history of solid organ transplant.
Unresolved toxicities from prior anticancer therapy, defined as having not resolved to Grade 0 or 1 (using NCI CTCAE version 5.0), except for alopecia and laboratory values listed in the inclusion criteria.
Receipt of any prior therapy targeting Globo H.

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Known hypersensitivity to OBI 999 or its excipients.
Has known untreated central nervous system metastases. Patients 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 co morbidity that is life threatening or, in the opinion of the Investigator, renders the patient unsuitable for participation in a clinical trial due to possible noncompliance, would place the patient at an unacceptable risk and/or potential to affect interpretation of results of the study.
Is receiving any concurrent prohibited medication

Trial locations and contacts

4 sites in 1 country.

United States4 sites

West Cancer Center
Germantown, Tennessee, 38138
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
Scripps MD Anderson Cancer Center
La Jolla, California, 92037
Memorial Sloan Kettering Cancer Center
New York, New York, 10065

Other trials in United States

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-999 in Patients With Advanced Solid Tumors

Conditions: Locally Advanced Solid Tumor
Being tested: OBI-999
Keywords: antibody drug conjugate (ADC)

What participants receive

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

OBI-999Drug
For the dose-escalation phase, OBI-999 will be administered on Day 1 of each 21-day cycle, for up to 35 cycles.
OBI-999Drug
For the dose-expansion phase, OBI-999 will be administered on Day 1 of each 21-day cycle, for up to 35 cycles.

Study groups in NCT04084366
Study group	Role	What they receive
OBI-999 Escalation phase	Experimental	Part A: Five cohorts at escalating dose levels 0.4, 0.8, 1.2, 1.6 and 2.0 mg/kg (capping calculations at a maximum at 100 kg) of OBI-999 liquid form via IV infusion to establish maximum tolerated dose (MTD) and Recommended phase 2 dose (RP2D). Receives: Drug: OBI-999
OBI-999 Expansion Phase	Experimental	Part B: Five cohorts of patients at RP2D of OBI-999 liquid form, as determined from Part A, via IV infusion. Receives: Drug: OBI-999

What is being measured

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

Objective Response Rate (ORR) (CR+PR)
Assessment of OBI-999 clinical benefit rate for dose escalation and cohort expansion phases of the OBI 999-001 study.
Measured: Every 6 weeks (±7 days) for first 3 months, then every 9 weeks (±7 days) until discontinuation of study treatment, disease progression, death, or initiation of further cancer therapy, or for up to 35 cycles (approximately 2 years.), whichever occurs first

Timeline

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

25 Nov 201927 Oct 2023

First posted10 Sep 2019
Study start25 Nov 2019
Primary completion27 Oct 2023
Study completion27 Oct 2023

Why it stopped: Has not shown its expected therapeutic potential for the enrolled patients in this trial

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Locally Advanced Solid TumorStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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
Masking: None (open label)
Enrolment: 44 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04084366
Sponsor's protocol ID: OBI-999-001
Status last verified: Mar 2025
First submitted: 5 Sep 2019
Last updated: 26 Mar 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Tsimberidou AM, Sigal D, Varghese A, Vaena D, Bai LY, Chen MH, Yeh CN, Yen CJ, Baysal MA, Chakraborty A, Lee I, Shia CS, Ristoski K, Xu D. Dose-expansion study of OBI-999, a Globo H-targeting antibody-drug conjugate, in patients with advanced solid tumors. Oncologist. 2026 Aug 6;31(9):oyag249. doi: 10.1093/oncolo/oyag249.
PubMed 42371780
Tsimberidou AM, Vo HH, Beck J, Shia CS, Hsu P, Pearce TE. First-in-Human Study of OBI-999, a Globo H-Targeting Antibody-Drug Conjugate, in Patients With Advanced Solid Tumors. JCO Precis Oncol. 2023 Jan;7:e2200496. doi: 10.1200/PO.22.00496.
PubMed 36701651

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
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A Study to Investigate the Safety, Pharmacokinetics, and Preliminary Efficacy of IDE574 Therapy in Adult Participants With Advanced Solid Tumors
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Active, not recruitingPhase 2
Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations
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A Study to Evaluate the Safety, Pharmacokinetics, and Activity of RO7566802 as a Single Agent and in Combination With Atezolizumab in Participants With Locally Advanced or Metastatic Solid Tumors
Locally Advanced Solid Tumors, Recurrent Solid Tumors

All Locally Advanced Solid Tumor trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1/2, Open-Label, Dose-Escalation and Cohort-Expansion Study Evaluating the Safety, Pharmacokinetics, and Therapeutic Activity of OBI-999 in Patients With Advanced Solid Tumors
ClinicalTrials.gov ID: NCT04084366
Acronym / sponsor ID: OBI-999-001
Conditions: Locally Advanced Solid Tumor
Keywords: antibody drug conjugate (ADC)
Phase: Phase 1/2
Study type: Interventional
Recruitment status: TerminatedReason stopped: Has not shown its expected therapeutic potential for the enrolled patients in this trial
Enrolment: 44 participants (actual)
Lead sponsor: OBI Pharma, IncIndustry (pharma, biotech, devices)
Study start: 25 Nov 2019 (actual)
Primary completion: 27 Oct 2023 (actual)
Study completion: 27 Oct 2023 (actual)
First posted: 10 Sep 2019 (actual)
Results: Posted 26 Mar 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
OBI-999 Escalation phase	Experimental	Drug: OBI-999Part A: Five cohorts at escalating dose levels 0.4, 0.8, 1.2, 1.6 and 2.0 mg/kg (capping calculations at a maximum at 100 kg) of OBI-999 liquid form via IV infusion to establish maximum tolerated dose (MTD) and Recommended phase 2 dose (RP2D).
OBI-999 Expansion Phase	Experimental	Drug: OBI-999Part B: Five cohorts of patients at RP2D of OBI-999 liquid form, as determined from Part A, via IV infusion.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (31 listed)

Male or female patients, 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 patients with advanced solid tumors.
Patients must have been treated with established standard-of-care therapy, or physicians have determined that such established therapy is not sufficiently efficacious, or patients have declined to receive standard-of-care therapy. In the latter case, the informed consent must state the effective therapies the patient is declining.
Measurable disease (i.e., at least one measurable lesion per RECIST 1.1)

Key exclusion criteria (11 listed)

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 999.
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 999.
Sensory or motor neuropathy of Grade 2 or greater.
Patients with a history of solid organ transplant.
Unresolved toxicities from prior anticancer therapy, defined as having not resolved to Grade 0 or 1 (using NCI CTCAE version 5.0), except for alopecia and laboratory values listed in the inclusion criteria.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
OBI-999For the dose-escalation phase, OBI-999 will be administered on Day 1 of each 21-day cycle, for up to 35 cycles.	Drug	OBI-999 Escalation phase
OBI-999For the dose-expansion phase, OBI-999 will be administered on Day 1 of each 21-day cycle, for up to 35 cycles.	Drug	OBI-999 Expansion Phase

Primary outcome

Objective Response Rate (ORR) (CR+PR)
Time frame: Every 6 weeks (±7 days) for first 3 months, then every 9 weeks (±7 days) until discontinuation of study treatment, disease progression, death, or initiation of further cancer therapy, or for up to 35 cycles (approximately 2 years.), whichever occurs first
Assessment of OBI-999 clinical benefit rate for dose escalation and cohort expansion phases of the OBI 999-001 study.

Results and safety

Results posted to the registry on 26 Mar 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Part A, Dose Escalation - OBI-999 0.4 mg/kg	3	0
Part A, Dose Escalation - OBI-999 0.8 mg/kg	3	0
Part A, Dose Escalation - OBI-999 1.2 mg/kg	6	0
Part A, Dose Escalation - OBI-999 1.6 mg/kg	3	0
Part B, Cohort Expansion - Cohort 1, Pancreatic	11	1
Part B, Cohort Expansion - Cohort 2, Colorectal Cancer	10	0
Part B, Cohort Expansion - Cohort 3, Basket (Any Other Solid Tumor Other Than Cohorts 1 and 2)	8	2

Primary outcome: Objective Response Rate (ORR) (CR+PR)

Time frame: Every 6 weeks (±7 days) for first 3 months, then every 9 weeks (±7 days) until discontinuation of study treatment, disease progression, death, or initiation of further cancer therapy, or for up to 35 cycles (approximately 2 years.), whichever occurs first. Number (95% Confidence Interval). Unit: % of participants

Measure	Part A, Dose Escalation - OBI-999 0.4 mg/kg n = 3	Part A, Dose Escalation - OBI-999 0.8 mg/kg n = 3	Part A, Dose Escalation - OBI-999 1.2 mg/kg n = 6	Part A, Dose Escalation - OBI-999 1.6 mg/kg n = 3	Part B, Cohort Expansion - Cohort 1, Pancreatic n = 7	Part B, Cohort Expansion - Cohort 2, Colorectal Cancer n = 8	Part B, Cohort Expansion - Cohort 3, Basket (Any Other Solid Tumor Other Than Cohorts 1 and 2) n = 8
Value	0 (0 to 70.8)	0 (0 to 70.8)	0 (0 to 45.9)	0 (0 to 70.8)	0 (0 to 41)	0 (0 to 36.9)	0 (0 to 36.9)

Population analysed: The efficacy population consists of all patients who are enrolled, have received at least 1 dose of study drug, and had at least one follow-up tumor assessment scan.

Adverse events

Time frame: Adverse event data were collected for up to approximately 2 years after first dose. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Part A, Dose Escalation - OBI-999 0.4 mg/kg	2 of 3 (66.7%)	3 of 3 (100%)	1 of 3
Part A, Dose Escalation - OBI-999 0.8 mg/kg	1 of 3 (33.3%)	3 of 3 (100%)	1 of 3
Part A, Dose Escalation - OBI-999 1.2 mg/kg	2 of 6 (33.3%)	5 of 6 (83.3%)	0 of 6
Part A, Dose Escalation - OBI-999 1.6 mg/kg	3 of 3 (100%)	3 of 3 (100%)	1 of 3
Part B, Cohort Expansion - Cohort 1, Pancreatic	8 of 11 (72.7%)	10 of 11 (90.9%)	3 of 11
Part B, Cohort Expansion - Cohort 2, Colorectal Cancer	2 of 10 (20%)	10 of 10 (100%)	1 of 10
Part B, Cohort Expansion - Cohort 3, Basket (Any Other Solid Tumor Other Than Cohorts 1 and 2)	0 of 8 (0%)	7 of 8 (87.5%)	1 of 8

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 42371780Tsimberidou AM, Sigal D, Varghese A, Vaena D, Bai LY, Chen MH, Yeh CN, Yen CJ, Baysal MA, Chakraborty A, Lee I, Shia CS, Ristoski K, Xu D. Dose-expansion study of OBI-999, a Globo H-targeting antibody-drug conjugate, in patients with advanced solid tumors. Oncologist. 2026 Aug 6;31(9):oyag249. doi: 10.1093/oncolo/oyag249.
Derived from this study: PubMed 36701651Tsimberidou AM, Vo HH, Beck J, Shia CS, Hsu P, Pearce TE. First-in-Human Study of OBI-999, a Globo H-Targeting Antibody-Drug Conjugate, in Patients With Advanced Solid Tumors. JCO Precis Oncol. 2023 Jan;7:e2200496. doi: 10.1200/PO.22.00496.
Individual participant dataSharing planned: No

Related trials for Locally Advanced Solid Tumor

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
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RecruitingPhase 1/2
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Apostolia Tsimberidou, MD, PhD principal investigator

M.D. Anderson Cancer Center

4 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing OBI-999 in people with Locally Advanced Solid Tumor, run by OBI Pharma, Inc at 4 sites in United States.

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 31 inclusion and 11 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: stopped early, as of the sponsor's last update on 26 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. 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?

Yes. Results are posted in the registry (first posted 26 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Objective Response Rate (ORR) (CR+PR) (time frame: Every 6 weeks (±7 days) for first 3 months, then every 9 weeks (±7 days) until discontinuation of study treatment, disease progression, death, or initiation of further cancer therapy, or for up to 35 cycles (approximately 2 years.), whichever occurs first). 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 NCT04084366, which also lists 2 linked publications.

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 26 Mar 2025.