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Monoclonal Antibodies

PRO1107 for Endometrial Cancer

Phase 1 & 2

Recruiting

Research Sponsored by ProfoundBio US Co.

Eligibility Criteria Checklist

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

Must have

Pathologically confirmed diagnosis of gastric or gastroesophageal junction (GEJ) adenocarcinoma

Endometrial cancer (any subtype excluding sarcoma)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through end of treatment, up to approximately 1 year

Awards & highlights

Study Summary

"This trial is testing a new drug called PRO1107 in patients with advanced solid tumors to see if it is safe, how well the body tolerates it, how the body processes it, and if

Who is the study for?

This trial is for adults with certain advanced solid tumors, including specific types of breast, ovarian, endometrial, gastroesophageal, bladder cancer and non-small cell lung cancer. Participants must have measurable disease after prior treatments and be in good physical condition (ECOG score 0 or 1). They also need to provide a tumor sample.Check my eligibility

What is being tested?

PRO1107 is being tested for safety and effectiveness against various advanced cancers. The study has two parts: Part A to find the right dose and expand it; Part B focuses on specific tumors. It's an open-label trial where everyone knows they're getting PRO1107.See study design

What are the potential side effects?

Specific side effects of PRO1107 are not listed here but generally may include typical reactions seen with cancer therapies such as nausea, fatigue, skin reactions or increased risk of infection.

Eligibility Criteria

Inclusion Criteria

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

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I have been diagnosed with stomach or gastroesophageal junction cancer.

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I have endometrial cancer, but it's not sarcoma.

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My breast cancer is triple negative.

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I have cancer in my stomach or where my esophagus meets my stomach.

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I have been diagnosed with esophageal squamous cell carcinoma.

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My cancer has spread, cannot be surgically removed, and has not responded to previous treatments.

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I am fully active or can carry out light work.

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My breast cancer is confirmed to be triple negative.

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I am fully active or restricted in physically strenuous activity but can do light work.

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My diagnosis is esophageal squamous cell carcinoma.

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I have been diagnosed with ovarian, peritoneal, or fallopian tube cancer.

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I have been diagnosed with endometrial cancer, not including sarcoma.

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My condition is confirmed non-small cell lung cancer.

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My cancer is in the bladder, ureter, or renal pelvis.

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My cancer has spread, cannot be surgically removed, and has not responded to previous treatments.

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My cancer is in the bladder, ureter, or renal pelvis.

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I have ovarian, peritoneal, or fallopian tube cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through end of treatment, up to approximately 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through end of treatment, up to approximately 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and through end of treatment, up to approximately 1 year for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Adverse Events

Dose limiting toxicity

Laboratory abnormalities

Secondary outcome measures

Disease Control Rate

Duration of objective response

Objective Response Rate

+6 more

Other outcome measures

Immunogenic potential of PRO1107

Trial Design

1Treatment groups

Experimental Treatment

Group I: PRO1107Experimental Treatment1 Intervention

PRO1107 monotherapy in escalating doses in Part A and at the two recommended phase 2 doses in Part B

0 / 17Eligibility criteria met

Find a Location

Who is running the clinical trial?

ProfoundBio US Co.Lead Sponsor

2 Previous Clinical Trials

268 Total Patients Enrolled

1 Trials studying Endometrial Cancer

134 Patients Enrolled for Endometrial Cancer

Frequently Asked Questions

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

Is the enrollment for this medical study currently open?

"As per the details on clinicaltrials.gov, this investigation is presently enrolling participants. The trial was originally published on January 29th, 2024 and last revised on February 2nd, 2024."

Answered by AI

What is the cumulative count of individuals participating in this research endeavor?

"Indeed, data on clinicaltrials.gov indicates that this particular trial is actively seeking participants. The study was first listed on 1/29/2024 and last revised on 2/2/2024. It aims to enroll 214 patients from two distinct sites."

Answered by AI

What is the primary goal of conducting this scientific study?

"The primary focus of this clinical trial, assessed over the treatment period spanning around 12 months, is to monitor laboratory irregularities. Secondary goals involve determining Pharmacokinetic parameter Tmax for PRO1107 (indicating the time taken to reach peak concentration in plasma), Pharmacokinetic parameter Ctrough for PRO1107 (representing minimum concentration in plasma), and Objective Response Rate assessing patients achieving partial or complete response based on RECIST v1.1 criteria."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

PRO1107 in Patients With Advanced Solid Tumors

2024. "PRO1107 in Patients With Advanced Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06171789.

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