Trial Title:
A Study of SGN-MesoC2 in Advanced Solid Tumors
NCT ID:
NCT06466187
Condition:
Carcinoma, Non-Small-Cell Lung
Ovarian Neoplasms
Pancreatic Adenocarcinoma
Colorectal Neoplasms
Mesothelioma
Other Solid Tumors
Conditions: Official terms:
Neoplasms
Mesothelioma
Colorectal Neoplasms
Carcinoma, Non-Small-Cell Lung
Ovarian Neoplasms
Conditions: Keywords:
NSCL
Lung Neoplasm
Cancer of Ovary
Ovarian Cancer
Colorectal Cancer
Colorectal Tumors
Seattle Genetics
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
SGN-MesoC2
Description:
Given into the vein (IV; intravenously)
Arm group label:
SGN-MesoC2
Other name:
HBM9033
Summary:
This clinical trial is studying advanced solid tumors. Solid tumors are cancers that
start in a part of your body like your lungs or liver instead of your blood. Once tumors
have grown bigger in one place but haven't spread, they're called locally advanced. If
your cancer has spread to other parts of your body, it's called metastatic. When a cancer
has gotten so big it can't easily be removed or has spread to other parts of the body, it
is called unresectable. These types of cancer are harder to treat.
Patients in this study must have cancer that has come back or did not get better with
treatment. Patients must have a solid tumor cancer that can't be treated with standard of
care drugs.
This clinical trial uses an experimental drug called SGN-MesoC2. SGN-MesoC2 is a type of
antibody-drug conjugate (ADC). ADCs are designed to stick to cancer cells and kill them.
They may also stick to some normal cells.
This study will have 3 parts. Part A and Part B of the study will find out how much
SGN-MesoC2 should be given to participants. Part C will use the information from Parts A
and B to see if SGN-MesoC2 is safe and if it works to treat solid tumor cancers.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- An Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1.
- Participants must have histologically- or cytologically-confirmed metastatic or
locally advanced unresectable ovarian cancer, non-small cell lung cancer (NSCLC),
pancreatic adenocarcinoma, colorectal cancer (CRC), mesothelioma, or other solid
tumors, have relapsed or progressed following standard therapies, or for which no
standard therapy is available.
- Must have at least one measurable lesion at baseline based on RECIST v1.1.
- Archival tumor tissue is required, or, if unavailable, a fresh tumor biopsy (if it
is safe and feasible) during the screening period.
- Participants weighing ≥40 kg
- Additional inclusion criterion for platinum resistant ovarian cancer (PROC)
participants: Histologically or cytologically documented invasive epithelial
ovarian, primary peritoneal, or fallopian tube cancer (tumors with pseudomyxomatous
or mucinous histology are excluded) or advanced predominantly epithelioid
peritoneal, must have relapsed or progressed following local standard therapies or
for which no standard therapy is available.
- Platinum prior exposure unless it is contraindicated or not available.
- Participants with known FRa high expression, must have progressed after mirvetuximab
soravtansine (if available or other FRa-directed therapy) unless contraindicated or
not available.
- Additional inclusion criterion for pancreatic ductal adenocarcinoma (PDAC)
participants: Histologically or cytologically documented, locally advanced
unresectable or metastatic pancreatic adenocarcinoma, including recurrence of
previously resected disease.
- Participant must have progressed after standard cytotoxic therapies, or for which no
standard therapy is available. Participants must have received fluoropyrimidine-,
oxaliplatin-, and irinotecan-based chemotherapy, gemcitabine and nab-paclitaxel
combination or gemcitabine-based chemotherapy.
- Additional inclusion criterion for NSCLC participants: Histologically or
cytologically confirmed advanced and/or metastatic NSCLC, must have progressed after
standard therapies, or for which no standard therapy is available.
- If participants have a specific mutation for which standard therapy is available
(eg, ALK, ROS1, MET, NTRK, BRAF V600E, EGFR Exon 20 ins, RET, KRAS G12C, HER2), they
must have documented progression after treatment with appropriate tyrosine kinase
inhibitor or other agent and have documented progression after platinum doublet
chemotherapy treatment, unless not tolerated, contraindicated, or not available.
- Additional inclusion criterion for CRC participants: Histologically confirmed
metastatic or locally advanced colorectal adenocarcinoma.
- Participant must have progressed after standard therapy, or for which no standard
therapy is available. Participants must have received fluoropyrimidine-,
oxaliplatin-, and irinotecan-based chemotherapy, unless not tolerated,
contraindicated, or not available.
- Participants with microsatellite instability (MSI)-H/mismatch repair deficient
(dMMR) tumors must have received treatment with a PD-1 mAb, unless not tolerated or
available. If participants have an BRAF mutation or other mutations, they must have
documented progression after treated with appropriate therapies (eg, encorafenib +
cetuximab), unless not tolerated or available. Particpants with HER2 positive
tumors, must have received treatment with HER2-directed therapies (eg, tucatinib +
trastuzumab), unless not tolerated or available.
- Additional inclusion criteria for EC participants: Participant must have received at
least 1 line of platinum-based chemotherapy.
- Participant must have received up to 2 lines of systemic therapy in metastatic
setting.
- If appropriate by biomarker status (including but not limited to microsatellite
instability [MSI] and dMMR status) and available per local SOC, must have received a
prior PD-1 inhibitor and/or the combination of pembrolizumab and lenvatinib, unless
not tolerated.
- Additional inclusion criteria for mesothelioma participants: Histologically or
cytologically confirmed advanced and/or metastatic mesothelioma, must have
progressed after standard therapies, or for which no standard therapy is available.
Exclusion Criteria:
- Participants previously received or is currently receiving the following anticancer
medications or investigational drugs will be excluded:
- Any systemic anticancer therapy or focal radiotherapy within 4 weeks prior to
first dose of SGN-MesoC2 or within 2 weeks prior to the first dose of
SGN-MesoC2 if the underlying disease has progressed on treatment.
- For Part C, prior anti-Mesothelin (MSLN) antibody (mAb or BsAb), MSLN-directed
ADC.
- Major surgery (excluding placement of vascular access) within 4 weeks, or minor
surgery within 7 days, prior to first dose of study intervention. Participants must
have recovered adequately from the toxicity or complications from the surgery prior
to starting SGN-MesoC2. Participants who have planned major surgery during the
treatment period must be excluded from the study.
- History of another malignancy within 3 years before the first dose of study
intervention, or any evidence of residual disease from a previously diagnosed
malignancy. Exceptions are malignancies with a negligible risk of metastasis or
death.
- Known to be positive for human immunodeficiency virus (HIV). Participants with
severe or uncontrolled systemic diseases, including uncontrolled hypertension,
uncontrolled diabetes mellitus, or active bleeding diatheses.
- Participants with medical history of clinically significant lung diseases (eg,
interstitial pneumonia, pneumonitis, pulmonary fibrosis, and severe radiation
pneumonitis) or who are suspected to have these diseases by imaging at screening
period.
- Previously untreated brain metastases. Participants who have received radiation or
surgery for brain metastases are eligible if therapy was completed at least 4 weeks
prior to initiation of study treatment, there is no evidence of central nervous
system (CNS) disease progression, and there is no requirement for chronic
corticosteroid therapy. Leptomeningeal metastases or spinal cord compression due to
disease.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
SCRI Oncology Partners
Address:
City:
Nashville
Zip:
37203
Country:
United States
Status:
Recruiting
Contact:
Last name:
Melanie Hurst
Phone:
615-979-9868
Investigator:
Last name:
Meredith Sellers Pelster
Email:
Principal Investigator
Facility:
Name:
South Texas Accelerated Research Therapeutics
Address:
City:
San Antonio
Zip:
78229
Country:
United States
Status:
Recruiting
Contact:
Last name:
Isabel Jimenez
Phone:
210-593-5265
Email:
isabel.jimenez@startsa.com
Investigator:
Last name:
Amita Patnaik
Email:
Principal Investigator
Facility:
Name:
START Mountain Region
Address:
City:
West Valley City
Zip:
84119
Country:
United States
Status:
Recruiting
Contact:
Last name:
Marie Asay
Phone:
801-907-4770
Email:
marie.asay@startthecure.com
Investigator:
Last name:
William McKean
Email:
Principal Investigator
Start date:
August 2, 2024
Completion date:
November 1, 2028
Lead sponsor:
Agency:
Seagen Inc.
Agency class:
Industry
Source:
Seagen Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06466187
