BridgeMD
GEN1047 for Solid Tumors - First in Human (FIH) Trial
EU CTIS ID: 2024-510722-10-00
What this study is testing
Dose Escalation Part: Determine the maximum tolerated dose (MTD) and/or maximum administered dose (MAD) and recommended phase 2 dose (RP2D), or dose(s) to be studied in the Expansion part Characterize the safety profile of GEN1047 Dose Expansion Part: Evaluate antitumor activity based on response assessment criteria (RECIST v1.1) Determine RP2D (unless determined in the Escalation part)
- Phase I and Phase II (Integrated)- First administration to humans
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Dose Escalation part: Subject must have histologically or cytologically confirmed solid tumor(s) in any of the following selected indications for which there is no further available standard therapy likely to confer clinical benefit (or subject is not a candidate or has previously refused such earlier available therapy), and for whom, in the opinion of the investigator, experimental therapy with GEN1047 may be beneficial (breast cancer, endometrial cancer, ovarian cancer, squamous non-small-cell lung cancer [NSCLC-SCC]).
- Dose Escalation part: Must have either recurrence after, or progression on or lack of response to available relevant standard of care (SoC) anticancer therapies; or are deemed intolerant to or ineligible for, standard curative therapy in the recurrent setting.
- Dose Escalation part: Must have at least 1 measurable lesion per RECIST v1.1. The measurable lesion(s) must be outside the field of radiation therapy (RT) if there was prior treatment with RT.
- Dose Escalation part: Must have an Eastern Cooperative Oncology Group performance status (ECOGPS) score of 0 to 1 at Screening and on C1D1 pretreatment.
- Dose Escalation part: Should provide a tumor tissue sample during the Screening period and prior to C1D1.
- Dose Escalation part: Provide all tumor-assessing pre-trial CT scans since failure of last prior therapy.
You likely can't join if
- Significant cardiovascular impairment within 6 months of the first dose of trial drug
- Subject with new or progressive brain metastases or spinal cord compression.
- Subject has a history of bowel obstruction related to underlying disease (for Expansion Part Stage 1).
- Subject has been exposed to any prior therapy with a compound targeting CD3 and/or B7H4 or cell based therapies.
- Current pneumonitis (any grade) including any radiological change of ongoing pneumonitis at baseline or history of non-infectious drug-, immune-, or radiation-related pneumonitis that required steroid.
See the full eligibility criteria
Who can join
- Dose Escalation part: Subject must have histologically or cytologically confirmed solid tumor(s) in any of the following selected indications for which there is no further available standard therapy likely to confer clinical benefit (or subject is not a candidate or has previously refused such earlier available therapy), and for whom, in the opinion of the investigator, experimental therapy with GEN1047 may be beneficial (breast cancer, endometrial cancer, ovarian cancer, squamous non-small-cell lung cancer [NSCLC-SCC]).
- Dose Escalation part: Must have either recurrence after, or progression on or lack of response to available relevant standard of care (SoC) anticancer therapies; or are deemed intolerant to or ineligible for, standard curative therapy in the recurrent setting.
- Dose Escalation part: Must have at least 1 measurable lesion per RECIST v1.1. The measurable lesion(s) must be outside the field of radiation therapy (RT) if there was prior treatment with RT.
- Dose Escalation part: Must have an Eastern Cooperative Oncology Group performance status (ECOGPS) score of 0 to 1 at Screening and on C1D1 pretreatment.
- Dose Escalation part: Should provide a tumor tissue sample during the Screening period and prior to C1D1.
- Dose Escalation part: Provide all tumor-assessing pre-trial CT scans since failure of last prior therapy.
- Dose Expansion part – Stage 1: Subjects must have documented PD according to RECIST v1.1 on or after last prior treatment with latest scan performed a maximum of 28 days prior to the first dose.
- Dose Expansion part – Stage 1b and 2: Subject must have advanced (unresectable) or metastatic, histologically confirmed diagnosis of breast cancer
- Dose Expansion part – Stage 1b and 2: Must have documented PD according to RECIST v1.1 on or after last prior treatment with latest scan performed a maximum of 28 days prior to the first dose.
- Dose Expansion part – Stage 1b and 2: Must be a female and at least 18 years of age (or the legal age of consent in the jurisdiction in which the trial is taking place) at the time of consent.
- Dose Expansion part – Stage 1b and 2: Must have at least 1 measurable lesion per RECIST v1.1 as assessed by the local investigator.
- Dose Expansion part – Stage 1: Subject must have advanced (unresectable) or metastatic, histologically confirmed diagnosis (breast cancer, endometrial cancer, ovarian cancer, squamous non-small cell lung cancer [NSCLC-SCC]).
- Dose Expansion part – Stage 1b and 2: Must have an ECOG-PS score of 0 to 1 at Screening and on C1D1 pretreatment.
- Dose Expansion part – Stage 1b and 2: Must provide a tumor tissue sample during the Screening period and prior to C1D1.
- Dose Expansion part – Stage 1: Must be a female and at least 18 years of age (or the legal age of consent in the jurisdiction in which the trial is taking place) at the time of consent.
- Dose Expansion part – Stage 1: Must have at least 1 measurable lesion per RECIST v1.1 as assessed by local investigator.
- Dose Expansion part – Stage 1: Must have an ECOG- PS score of 0 to 1 at Screening and on Cycle 1 Day 1 (C1D1) pretreatment.
- Dose Expansion part – Stage 1: Must provide a tumor tissue sample during the Screening period and prior to C1D1.
- Dose Expansion part – Stage 1: Provide all tumor-assessing pre-trial CT scans since failure of last prior therapy.
- Dose Escalation part: Subjects with ovarian cancer must have documented progressive disease (PD) on or after last prior treatment and within 60 days of Screening.
- Dose Escalation part: Must be at least 18 years of age (or the legal age of consent in the jurisdiction in which the trial is taking place) on the day of signing informed consent.
What rules you out
- Significant cardiovascular impairment within 6 months of the first dose of trial drug
- Subject with new or progressive brain metastases or spinal cord compression.
- Subject has a history of bowel obstruction related to underlying disease (for Expansion Part Stage 1).
- Subject has been exposed to any prior therapy with a compound targeting CD3 and/or B7H4 or cell based therapies.
- Current pneumonitis (any grade) including any radiological change of ongoing pneumonitis at baseline or history of non-infectious drug-, immune-, or radiation-related pneumonitis that required steroid.
The study team makes the final eligibility decision.
Where it's taking place
- United Kingdom
- United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United Kingdom; United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.