GlioblastomaPhase 1NCT04933422
CM93 Treatment in Subjects With Epidermal Growth Factor Receptor (EGFR)-Modified Recurrent Glioblastoma (rGBM)
A Phase 1 study testing CM93 in people with Glioblastoma, run by Crimson Biopharm Inc..
Trial summary
This is a first-in-human study of CM93, an oral investigational drug, in adults with Epidermal Growth Factor Receptor-modified glioblastoma. The study is designed in three parts consisting of a dose-escalation phase, a dose-expansion phase and a window-of-opportunity surgical trial. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioblastoma
- What is being tested?
- CM93
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- No sites listed yet
- Study dates
- Jan 2027to Jul 2029
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have histologically confirmed recurrent or progressive World Health Organization IV isocitrate dehydrogenase (IDH) wild type glioblastoma and variants, including high-grade astrocytoma with molecular features of glioblastoma (WHO grade IV).
- Archival tumor from initial or other prior surgery is documented to have EGFR mutation or EGFR amplification
- Previous first line therapy with at least radiotherapy utilizing standard dosing of CNS radiation with or without chemotherapy.
- Patients must have shown unequivocal evidence of tumor progression by MRI and have confirmed measurable disease per RANO criteria.
- Patients must have confirmation of availability of sufficient tissue from prior surgery revealing glioblastoma or variants for submission following registration for repeat EGFR mutation testing and additional sequencing. The following amount of tissue is required:
- 1 formalin-fixed paraffin-embedded (FFPE) tumor tissue block (preferred), or
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- 20 FFPE unstained slides (5 µm thickness)
- Patients must have recovered to grade 0 or 1 as determined by the National Cancer Institute CTCAE version 5.0 or pre-treatment baseline from clinically significant toxic effects of prior therapy (including but not limited to exceptions for alopecia, laboratory values listed per inclusion criterion 3.1.12, and lymphopenia which is common after therapy with temozolomide).
- An interval of at least 4 weeks (to registration) between prior surgical resection or one week from stereotactic biopsy.
- Age ≥18 years. Because no dosing or adverse event data are currently available on the use of CM93 in participants <18 years of age, children are excluded from this study, but will may be eligible for future pediatric trials.
- Karnofsky performance status ≥ 60 (Appendix A).
- Participants must have adequate organ and marrow function as defined below:
- absolute neutrophil count ≥1,500/mcL
- hemoglobin ≥ 9g/dL
- platelets ≥100,000/mcL
- total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN) (subjects with Gilbert syndrome are allowed if direct bilirubin within normal limits)
- AST(SGOT)/ALT(SGPT) ≤3 × institutional ULN
- creatinine ≤1.5mg/dL or a calculated creatinine clearance ≥60mL/min
- negative serum beta-hCG test in women of childbearing potential (defined as women ≤50 years of age, or >50 years of age with a history of amenorrhea ≤12 months prior to study entry).
- Left ventricular ejection fraction (LVEF) at least 50% by echocardiogram or multigated acquisition scan (MUGA).
- Participants with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, participants should be class 2B or better.
- The effects of CM93 on the developing human fetus are unknown. For that reason, women of childbearing age must agree to use dual contraceptive methods which, in the opinion of the principal investigator, are effective and adequate for that subject's circumstances while on study drug and for 4 months afterward.
- Men who partner with a woman of childbearing potential must agree to use effective, dual contraceptive methods (i.e., a condom, with female partner using oral, injectable or barrier method) while on study drug and for 4 months afterward.
- Ability to understand and the willingness to sign a written informed consent document.
- Additional criteria for window-of-opportunity surgical cohort
- Patients must be undergoing surgery for recurrent or progressive disease that is clinically indicated as determined by their care providers.
- Ability of a neurosurgeon to gross or subtotally resect both enhancing and non-enhancing components of the tumor and that sufficient tissue can be obtained from each component for correlative studies.
Who cannot join
- 1. Prior evidence of IDH mutation by IHC or DNA sequencing (i.e., IDH wild type only)
- 2. Participants who have had prior treatment with any EGFR inhibitor, or VEGF or VEGFR inhibitor.
- 3. Participants who have had temozolomide less than 23 days from study initiation, treatment with CCNU or BCNU less than 42 days from study initiation, or treatment with any cancer-directed systemic therapy less than 4 weeks or 5 half-lives from study initiation, whichever is shorter.
- 4. Participants who have had any cancer-directed immunomodulatory or molecularly-targeted agent or monoclonal antibody within 14 days prior to initiation of study drug.
- 5. Participants who have used any investigational agents within 28 days or 5 half-lives from study initiation, whichever is shorter.
- 6. For phase 1 dose escalation and dose expansion: increasing corticosteroid requirement or a dose >6 mg per day of dexamethasone or equivalent dose of other corticosteroids within 7 days prior to study initiation. This does not apply to patients in the window-of-opportunity surgical trial.
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- 7. Participants who received radiation therapy within 12 weeks prior to registration, unless there is surgical confirmation of recurrent disease or evidence of new enhancing recurrent disease outside of the prior radiotherapy treatment field.
- 8. Participants with major surgery within the last 28 days prior to registration.
- 9. History of allergic reactions attributed to compounds of similar chemical or biologic composition to CM93.
- 10. Participants receiving any medications or substances that are strong inhibitors of CYP3A4 (e.g., clarithromycin, azole antifungals, protease inhibitors, nefazadone, grapefruit juice) or those metabolized by CYP 3A4/3A5 are ineligible. Caution is advised for participants taking dexamethasone as well as strong inducer(s) of its metabolism. Because the lists of these agents are constantly changing, it is important to regularly consult a frequently-updated medical reference. As part of the enrollment/informed consent procedures, the participant will be counseled on the risk of interactions with other agents, and what to do if new medications need to be prescribed or if the participant is considering a new over-the-counter medicine or herbal product.
- 11. Participants with known human immunodeficiency virus or acquired immunodeficiency syndrome-related illness.
- 12. Participants with any of the following within 6 months prior to initiation of study drug: uncontrolled congestive heart failure (New York Heart Association Classification 3 or 4), angina, myocardial infarction, cerebrovascular accident, coronary/peripheral artery bypass graft surgery, transient ischemic attack.
- 13. Pulmonary embolism within 1 month prior to initiation of study drug.
- 14. Unstable cardiac dysrhythmias or persistent prolongation of the QTc (Fridericia) interval to >450msec for males or >470msec for females.
- 15. Any contraindication to contrast-enhanced MRI examination.
- 16. Evidence of Grade ≥ 2 intracranial hemorrhage.
- 17. Participants with any severe, acute, or chronic medical or psychiatric condition, or laboratory abnormality that may increase the risk associated with study participation or study drug administration, may interfere with the informed consent process and/or with compliance with the requirements of the study, or may interfere with the interpretation of study results and, in the Investigator's opinion, would make the subject inappropriate for entry into this study.
- 18. Participants with uncontrolled intercurrent illness, including active or clinically unstable bacterial, viral or fungal infection requiring systemic therapy.
- 19. Pregnant women are excluded from this study; there are no reproductive toxicity data at the stage of development in animals. CM93 may have potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with CM93, breastfeeding should be discontinued if the mother is treated with CM93.
- 20. Previous malignancy, except for non-squamous cell cancer of the skin or carcinoma in situ of the uterine or cervix, unless the natural history or treatment of the tumor does not interfere with the safety or efficacy assessment of the investigational regimen.
- 21. Participants with difficulty swallowing/unable to swallow pills; malabsorption syndrome; refractory nausea and vomiting, chronic gastrointestinal (GI) disease or previous significant bowel resection with clinically significant sequelae that would preclude adequate absorption of study drug.
- Additional criteria for window-of-opportunity surgical cohort
- 22. Participants with >2 prior relapses of glioblastoma.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Phase 1 Study Evaluating the Safety, Pharmacokinetics, Pharmacodynamics and Clinical Effects of CM93 in Subjects With Recurrent Glioblastoma (rGBM) Characterized by Epidermal Growth Factor Receptor (EGFR) Mutation or Amplification
This is a first-in-human study of CM93, an oral investigational drug, in adults with Epidermal Growth Factor Receptor-modified glioblastoma. The study is designed in three parts consisting of a dose-escalation phase, a dose-expansion phase and a window-of-opportunity surgical trial. The trial objectives are to evaluate the safety, pharmacokinetics, pharmacodynamics and clinical effects of CM93 in this patient population.
Read the detailed description
CM93 is a third-generation, covalent/irreversible, brain penetrant small molecule Epidermal Growth Factor Receptor (EGFR) tyrosine kinase inhibitor. It is not a substrate of p-glycoprotein or breast cancer resistance protein (bcrp) and is a mild inhibitor of bcrp. It is a potent inhibitor of EGFR mutations but also has activity against wild type EGFR.
This first-in-human phase I trial will evaluate the safety, tolerability, and pharmacokinetics (PK) of CM93 and determine the recommended Phase 2 dose (RP2D) for further evaluation using a 3+3 design (Part 1). Once the RP2D has been determined 12 additional patients will be treated in a dose expansion cohort to confirm the safety and tolerability of the selected dose (Part 2). Subsequent to the phase I trial a window-of-opportunity surgical trial will initiate. Tumor from both contrast enhancing and non-contrast enhancing areas of patients who received CM93 before surgery will be resected and evaluated to determine if therapeutic concentrations of the drug are achieved. Pharmacodynamic studies will be conducted in tumor tissue from patients who received CM93 before surgery and the patients who did not receive drug before surgery to determine if there is adequate inhibition of EGFR. After recovery from surgery all 30 patients will receive CM93 until progression, development of unacceptable toxicity, or withdrawal of consent and preliminary evidence of activity will be obtained.
- Conditions
- Glioblastoma
- Being tested
- CM93
- Keywords
- EGFR, rGBM, EGFR-altered rGBM
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CM93Drug
Also called N-(5-((4-(1H-pyrrolo[2,3-b]pyridin-1-yl)pyrimidin-2-yl)amino)-2-((2-(dimethylamino)ethyl)(methyl)amino)-4-methoxyphenyl)acrylamide 4-methylbenzenesulfonate
oral capsule of CM93 administered once daily
| Study group | Role | What they receive |
|---|---|---|
| CM93 pre-treatment arm | Experimental | Applicable only for part 3 of this trial (surgical window of opportunity), pre-treatment with CM93 prior to surgical resection of recurrent glioblastoma Receives: Drug: CM93 |
| No pre-treatment arm | No intervention | Applicable only for part 3 of this trial (surgical window of opportunity), no pre-treatment prior to surgical resection of recurrent glioblastoma |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-limiting toxicities
Record and compare safety and tolerability, adverse events, changes in laboratory parameters and electrocardiogram measure of patients to baseline measurements. DLTs (dose-limiting toxicities) are defined as a clinically significant adverse event (AE) or laboratory abnormality unrelated to disease progression that meet certain criteria.
Measured: 28 days
Maximum tolerated dose
The MTD (maximum tolerated dose) is defined as the highest dose level at which ≤1 of 6 subjects experience a DLT during Cycle 1 (the first 28 days of intervention).
Measured: 28 days
Recommended phase 2 dose
Determined by the DSMC (Data Safety Monitoring Committee) after review of safety data, the RP2D (recommended phase 2 dose) will be the MTD unless:
- Significant clinical anti-tumor effect (complete response, partial response, or stable disease for ≥2 months) is seen below the MTD, in which case a clinically active dose level may be selected as an RP2D; or
- Toxicities observed beyond Cycle 1 require reducing the RP2D(s) below the MTD level; or
- MTD is not achieved, in which case the highest dose level administered may become an RP2D.
Measured: 28 days
Concentration of CM93 in non-enhancing areas of tumor
In part 3 of the study, tissue samples from non-enhancing areas of the tumor will be analyzed for CM93 and concentration will be reported for the CM93-treated group.
Measured: 7 days
Secondary outcomes (5)
Half-life of CM93
Calculate half-life from the plasma bioanalysis of CM93 and its active metabolite at different time points and doses.
Measured: 22 days
Maximum plasma concentration (Cmax)
Calculate Cmax from the plasma bio analysis of CM93 and its active metabolite.
Measured: 22 days
Time to Maximum plasma concentration (Tmax)
Calculate Tmax from the plasma bio analysis of CM93 and its active metabolite.
Measured: 22 days
Area under the curve (AUC)
Calculate AUC from the plasma bio analysis of CM93 and its active metabolite.
Measured: 22 days
EGFR level in tumor specimens
In part 3 of the study, average pEGFR (phosphorylated epidermal growth factor receptor) levels in the tumor specimens of CM93-treated surgical patients will be compared to the levels in tumor specimens from untreated patients and difference between the two groups noted.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2021
- Study startJan 2027 (estimated)
- Primary completionJul 2029 (estimated)
- Study completionJul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlioblastomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Crimson Biopharm Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04933422
- Sponsor's protocol ID
- CM93-101
- Status last verified
- Aug 2024
- First submitted
- 24 May 2021
- Last updated
- 21 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Study Evaluating the Safety, Pharmacokinetics, Pharmacodynamics and Clinical Effects of CM93 in Subjects With Recurrent Glioblastoma (rGBM) Characterized by Epidermal Growth Factor Receptor (EGFR) Mutation or Amplification
- ClinicalTrials.gov ID
- NCT04933422
- Acronym / sponsor ID
- CM93-101
- Conditions
- Glioblastoma
- Keywords
- EGFR, rGBM, EGFR-altered rGBM
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Crimson Biopharm Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2027 (estimated)
- Primary completion
- Jul 2029 (estimated)
- Study completion
- Jul 2029 (estimated)
- First posted
- 21 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a first-in-human study of CM93, an oral investigational drug, in adults with Epidermal Growth Factor Receptor-modified glioblastoma. The study is designed in three parts consisting of a dose-escalation phase, a dose-expansion phase and a window-of-opportunity surgical trial. The trial objectives are to evaluate the safety, pharmacokinetics, pharmacodynamics and clinical effects of CM93 in this patient population.
Detailed description
CM93 is a third-generation, covalent/irreversible, brain penetrant small molecule Epidermal Growth Factor Receptor (EGFR) tyrosine kinase inhibitor. It is not a substrate of p-glycoprotein or breast cancer resistance protein (bcrp) and is a mild inhibitor of bcrp. It is a potent inhibitor of EGFR mutations but also has activity against wild type EGFR.
This first-in-human phase I trial will evaluate the safety, tolerability, and pharmacokinetics (PK) of CM93 and determine the recommended Phase 2 dose (RP2D) for further evaluation using a 3+3 design (Part 1). Once the RP2D has been determined 12 additional patients will be treated in a dose expansion cohort to confirm the safety and tolerability of the selected dose (Part 2). Subsequent to the phase I trial a window-of-opportunity surgical trial will initiate. Tumor from both contrast enhancing and non-contrast enhancing areas of patients who received CM93 before surgery will be resected and evaluated to determine if therapeutic concentrations of the drug are achieved. Pharmacodynamic studies will be conducted in tumor tissue from patients who received CM93 before surgery and the patients who did not receive drug before surgery to determine if there is adequate inhibition of EGFR. After recovery from surgery all 30 patients will receive CM93 until progression, development of unacceptable toxicity, or withdrawal of consent and preliminary evidence of activity will be obtained.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CM93 pre-treatment arm | Experimental | Drug: CM93Applicable only for part 3 of this trial (surgical window of opportunity), pre-treatment with CM93 prior to surgical resection of recurrent glioblastoma |
| No pre-treatment arm | No intervention | –Applicable only for part 3 of this trial (surgical window of opportunity), no pre-treatment prior to surgical resection of recurrent glioblastoma |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (27 listed)
- Have histologically confirmed recurrent or progressive World Health Organization IV isocitrate dehydrogenase (IDH) wild type glioblastoma and variants, including high-grade astrocytoma with molecular features of glioblastoma (WHO grade IV).
- Archival tumor from initial or other prior surgery is documented to have EGFR mutation or EGFR amplification
- Previous first line therapy with at least radiotherapy utilizing standard dosing of CNS radiation with or without chemotherapy.
- Patients must have shown unequivocal evidence of tumor progression by MRI and have confirmed measurable disease per RANO criteria.
- Patients must have confirmation of availability of sufficient tissue from prior surgery revealing glioblastoma or variants for submission following registration for repeat EGFR mutation testing and additional sequencing. The following amount of tissue is required:
Key exclusion criteria (23 listed)
- 1. Prior evidence of IDH mutation by IHC or DNA sequencing (i.e., IDH wild type only)
- 2. Participants who have had prior treatment with any EGFR inhibitor, or VEGF or VEGFR inhibitor.
- 3. Participants who have had temozolomide less than 23 days from study initiation, treatment with CCNU or BCNU less than 42 days from study initiation, or treatment with any cancer-directed systemic therapy less than 4 weeks or 5 half-lives from study initiation, whichever is shorter.
- 4. Participants who have had any cancer-directed immunomodulatory or molecularly-targeted agent or monoclonal antibody within 14 days prior to initiation of study drug.
- 5. Participants who have used any investigational agents within 28 days or 5 half-lives from study initiation, whichever is shorter.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CM93Also: N-(5-((4-(1H-pyrrolo[2,3-b]pyridin-1-yl)pyrimidin-2-yl)amino)-2-((2-(dimethylamino)ethyl)(methyl)amino)-4-methoxyphenyl)acrylamide 4-methylbenzenesulfonateoral capsule of CM93 administered once daily | Drug | CM93 pre-treatment arm |
Primary outcome
Dose-limiting toxicities
Time frame: 28 days
Record and compare safety and tolerability, adverse events, changes in laboratory parameters and electrocardiogram measure of patients to baseline measurements. DLTs (dose-limiting toxicities) are defined as a clinically significant adverse event (AE) or laboratory abnormality unrelated to disease progression that meet certain criteria.
Maximum tolerated dose
Time frame: 28 days
The MTD (maximum tolerated dose) is defined as the highest dose level at which ≤1 of 6 subjects experience a DLT during Cycle 1 (the first 28 days of intervention).
Recommended phase 2 dose
Time frame: 28 days
Determined by the DSMC (Data Safety Monitoring Committee) after review of safety data, the RP2D (recommended phase 2 dose) will be the MTD unless: * Significant clinical anti-tumor effect (complete response, partial response, or stable disease for ≥2 months) is seen below the MTD, in which case a clinically active dose level may be selected as an RP2D; or * Toxicities observed beyond Cycle 1 require reducing the RP2D(s) below the MTD level; or * MTD is not achieved, in which case the highest dose level administered may become an RP2D.
Concentration of CM93 in non-enhancing areas of tumor
Time frame: 7 days
In part 3 of the study, tissue samples from non-enhancing areas of the tumor will be analyzed for CM93 and concentration will be reported for the CM93-treated group.
5 secondary outcomes
Half-life of CM93
Time frame: 22 days
Maximum plasma concentration (Cmax)
Time frame: 22 days
Time to Maximum plasma concentration (Tmax)
Time frame: 22 days
Area under the curve (AUC)
Time frame: 22 days
EGFR level in tumor specimens
Time frame: 7 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CM93 in people with Glioblastoma, run by Crimson Biopharm Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 27 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 21 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact NeuroOnc Coordinator (617-632-2166, NeuroOnc_Coor@dfci.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose-limiting toxicities (time frame: 28 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2024.