M3541 in Combination With Radiotherapy in Subjects With Solid Tumors

Therapuetic Areas:Oncology
Age Range:18 - Any
Start Date:October 23, 2017
End Date:December 31, 2019
Contact:US Medical Information

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A Phase I, Open-label, Uncontrolled, Multicenter, Dose-escalation Study of M3541 in Combination With Palliative Radiotherapy in Subjects With Solid Tumors

This dose-escalation study will evaluate the safety, tolerability, pharmacokinetic (PK),
pharmacodynamic, and explore antitumor activity of M3541 in combination with fractionated
palliative radiotherapy (RT) in subjects with solid tumors with malignant lesions in the
thorax, abdominal cavity, head and neck region, or extremities likely to benefit from
palliative RT.

Inclusion Criteria:

- Subjects must have solid tumors with malignant lesions in the thorax, abdominal
cavity, head and neck region, or extremities (any histology) likely to benefit from
palliative radiotherapy; subjects requiring palliative RT for lesions in the spine or
lesions adjacent to the spinal cord are excluded from this study

- Eastern Cooperative Oncology Group performance status (ECOG PS) =< 2

- Life expectancy >= 3 months

- Adequate hematologic, hepatic, and renal function

- Agree to use highly effective contraception (that is, methods with a failure rate of
less than 1 percent per year) if the subject is male or a female of childbearing
potential (female partners of childbearing potential of male subjects must also agree
to use highly effective contraception)

- Other protocol defined inclusion criteria could apply

Exclusion Criteria:

- Use of other anticancer therapy within 15 days before the first dose of M3541
administration and should not be within the "at risk follow-up period" for that
specific anticancer therapy. The use of any investigational agent is not allowed
within 28 days before the first dose of M3541

- Residual toxicity due to previous anticancer therapy with no return to baseline or =<
Grade 1 (except alopecia) according to CTCAE V4.03

- Extensive prior RT on more than 30 percent of bone marrow reserves (by Investigator
judgment), or prior bone marrow/stem cell transplantation within 5 years before study

- Prior RT to the same region that would be irradiated in this study

- Subjects at increased risk for radiation toxicities, such as known collagen vascular
disease (example, scleroderma, Sjogren's disease, etc) or other inherited radiation
hypersensitivity syndromes (example, Gorlin syndrome, Fanconi anemia,
ataxia-telangiectasia, etc.)

- Surgical intervention within 28 days prior to the first dose of M3541 administration

- Known central nervous system metastases causing clinical symptoms or metastases that
require therapeutic intervention. Subjects with a history of treated central nervous
system (CNS) metastases (by surgery or radiation therapy) are not eligible unless they
have fully recovered from treatment, demonstrated no progression for at least 2
months, and do not require continued steroid therapy. Subjects with CNS metastases
incidentally detected during Screening that do not cause clinical symptoms and for
which standard of care suggests no therapeutic intervention is indicated, should be
discussed with the Sponsor Medical Responsible

- Active difficulty swallowing, malabsorption or other chronic gastrointestinal disease
or conditions (including pancreas deficiency requiring Creon therapy) that may hamper
compliance and/or absorption of M3541

- Subjects currently receiving or unable to stop using medications or herbal supplements
known to be potent inhibitors of cytochrome P450 (CYP) 3A and / or P-glycoprotein
(P-gp) (CYP and / P-gp must stop at least 1 week before treatment with M3541) or
potent inducers of CYP3A or P-gp (must stop at least 3 weeks before treatment with
M3541) or drugs mainly metabolized by CYP3A with a narrow therapeutic index (must stop
at least 1 day prior).

- Other protocol defined exclusion criteria could apply
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