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Monoclonal Antibodies

OBI-999 for Advanced Cancers

Phase 1 & 2

Waitlist Available

Led By Apostolia Tsimberidou, MD, PhD

Research Sponsored by OBI Pharma, Inc

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Cohort 1: Pancreatic cancer

Cohort 2: Esophageal cancer

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 1 to week 106

Awards & highlights

Study Summary

This trial is testing a new drug to see what the maximum amount someone can take without having severe side effects, as well as what dose could be recommended for further studies.

Who is the study for?

This trial is for adults with advanced solid tumors, specifically pancreatic, esophageal, gastric, or colorectal cancer. Participants must have tried standard treatments without success or declined them and have a good performance status (able to carry out daily activities). They need functioning major organs and agree to use contraception. Those with HIV or hepatitis are eligible under certain conditions.Check my eligibility

What is being tested?

The study tests OBI-999 as a solo treatment to find the highest dose patients can tolerate without severe side effects (MTD) and the recommended dose for future Phase 2 trials (RP2D). It also aims to understand how safe OBI-999 is and its preliminary effectiveness in shrinking or controlling tumor growth.See study design

What are the potential side effects?

Specific side effects of OBI-999 aren't listed but typically include reactions related to the immune system's response, potential organ inflammation due to drug toxicity, general discomforts like fatigue or nausea, and possibly changes in blood counts leading to increased infection risk.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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This study is specifically for people with pancreatic cancer.

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This study is looking for people with esophageal cancer to participate in Cohort 2.

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This clinical trial is for people with gastric cancer specifically.

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This study is specifically looking for people with colorectal cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 1 to week 106

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 1 to week 106

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 1 to week 106 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Identification of a maximum tolerated dose and recommended phase 2 dose for OBI-999

Measurement of dose-limiting toxicities (DLTs)

Secondary outcome measures

Measurement of OBI-999 immunogenicity (anti-drug antibodies ([ADAs]) in patients

Measurement of preliminary clinical activity profile (clinical benefit rate [CBR]) of OBI-999 in patients.

Measurement of preliminary clinical activity profile (duration of response (DOR)]) of OBI-999 in patients.

+8 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: OBI-999 Expansion PhaseExperimental Treatment1 Intervention

Part B: Five cohorts of patients at RP2D of OBI-999 liquid form, as determined from Part A, via IV infusion.

Group II: OBI-999 Escalation phaseExperimental Treatment1 Intervention

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).

0 / 4Eligibility criteria met

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Who is running the clinical trial?

OBI Pharma, IncLead Sponsor

7 Previous Clinical Trials

1,370 Total Patients Enrolled

Apostolia Tsimberidou, MD, PhDPrincipal InvestigatorM.D. Anderson Cancer Center

3 Previous Clinical Trials

114 Total Patients Enrolled

Media Library

OBI-999 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04084366 — Phase 1 & 2

Solid Tumors Research Study Groups: OBI-999 Expansion Phase, OBI-999 Escalation phase

Solid Tumors Clinical Trial 2023: OBI-999 Highlights & Side Effects. Trial Name: NCT04084366 — Phase 1 & 2

OBI-999 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04084366 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any empty slots currently available for this research program?

"Affirmative. According to clinicaltrials.gov, this investigation is currently recruiting participants, which began on December 10th 2019 and was recently refreshed on July 5th 2022. 185 individuals are required at 4 sites for the study's completion."

Answered by AI

What aims does this trial seek to attain?

"This research study's primary objective is to determine the maximum tolerated dose of OBI-999 and an ideal dosage for Phase 2. Secondary aims include analysing pharmacokinetic parameters such as time to peak concentration (Tmax) and volume of distribution (Vd), along with assessing preliminary clinical activity profiles in terms of duration of response (DOR). The data collection period will cover 21 consecutive days per cycle."

Answered by AI

Are there numerous venues providing access to this research?

"Several research centres are taking part in this trial, including the University of Texas MD Anderson Cancer Center in Houston and West Cancer Center located in Germantown. The Scripps MD Anderson Cancer Centre based in La Jolla is also participating amongst a few other sites."

Answered by AI

To what extent is participation in this trial widespread?

"This clinical trial is looking to bring on board 185 participants who meet the particular criteria for inclusion. Those interested in taking part can reach out to University of Texas MD Anderson Cancer Center within Houston, or West Cancer Center near Germantown, Tennessee."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2019. "Phase 1/2 Study of OBI-999 in Patients With Advanced Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04084366.