Clinical Trials
A clinical study to evaluate the investigational medicine PLN-101095 + pembrolizumab for the treatment of solid tumors in certain types of cancer
FORTIFY is a Phase 1b clinical study for adults (18 years or older). The study is examining the preliminary efficacy (how well it works), safety, and tolerability of an investigational medicine called PLN-101095 in combination with the immune checkpoint inhibitor (ICI) pembrolizumab (KEYTRUDA®). The PLN-101095/pembrolizumab combination is being studied in people with certain kinds of solid tumors that are advanced or metastatic (where the cancer has spread to other parts of the body). Eligible participants will have had success with an ICI (pembrolizumab or another anti-PD-1 or anti-PD-L1) but then had their treatment stop working. FORTIFY is an open-label study, meaning participants, study doctors and study staff know what treatment is being received. In this study, all participants will receive the study drug and no one will receive a placebo (inactive treatment).
What is PLN-101095?
Treatment using ICIs has made a real difference for many people with cancer, but sometimes the ICIs stop working. Research shows that when ICIs stop working, it may be due, in part, to increases in something called TGF-β. Based on these findings, it is thought that blocking TGF-β may help ICIs to work better and possibly improve outcomes.
PLN-101095 is an investigational medicine that is thought to block TGF-β. We are conducting this study to test this hypothesis and better understand the safety and tolerability of PLN-101095 in combination with an ICI.
How PLN-101095 could possibly help people with cancer
Who can participate in FORTIFY?
To participate in FORTIFY, a person must:
- Be 18 years of age or older
- Have one of the following types of cancer, and it must be advanced or metastatic
- Non-small–cell lung cancer (NSCLC)
- Kidney cancer (specifically, clear cell renal cell carcinoma, or ccRCC)
- Melanoma*
- Colorectal cancer (CRC)*
- Bile duct cancer (cholangiocarcinoma)*
- Gallbladder cancer*
- Cancer of the uterus (endometrial cancer)*
- Cancer of the urinary tract (urothelial cancer)*
- Have had 12 or more weeks of successful anti-PD-1 or anti-PD-L1 treatment that then stops working (treatment does not have to have been immediately prior to participation in FORTIFY)
*These tumors must be classified as tumor mutational burden-high (TMB-H).
People eligible to participate in FORTIFY will have had:
There are other criteria that must be met to be eligible for participation. Study staff will help people determine eligibility.
What is involved in participation?
FORTIFY participants will undergo a screening period, a treatment period, and a follow-up period.
Screening period
- Up to 28 days
- One or more site visits
Treatment period
Initial treatment
- Up to 13 weeks
- Site visits at weeks 1, 2, 3, 4, 6, 9, 12
- PLN-101095 twice daily for 2 weeks
- PLN-101095 twice daily + pembrolizumab every 3 weeks for 7 weeks
Ongoing treatment
- Ongoing site visits
- If treatment is working, continue PLN-101095 + pembrolizumab for the duration of the study
Follow-up period
- One site visit 4 weeks after treatment
- Phone calls at 16 weeks, 6 months, 1 year
At the study site visits, participants will undergo some or all of the following assessments (depending on the site visit):
- Physical exam
- Health-related questions
- Blood draw(s)
- An electrocardiogram (ECG)
- Tumor assessments
Participation in FORTIFY is voluntary. Participants can change their mind at any time.
FORTIFY is currently enrolling at the following locations, additional sites to be added soon.
PLN-101095 is an investigational drug and is not approved by any health authority.
KEYTRUDA is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.
PD-1=programmed death-1; PD-L1=programmed death-ligand 1; TGF-β=transforming growth factor beta; TMB-H=tumor mutational burden-high.