NCT07392957
- Objective
- Not yet disclosed
- Design
- Not yet disclosed
- Participants
- Not yet disclosed
- Primary endpoint
- Not yet disclosed
- Results
- Results not yet reported
biotech · PTSD - Post Traumatic Stress Disorder · P1b: Advanced Solid Tumors · CMPX
Compass Therapeutics
Compass Therapeutics is a biotech organization headquartered in Boston, USA. It trades on NYSE under ticker CMPX. Primary therapeutic focus areas include PTSD - Post Traumatic Stress Disorder, P1b: Advanced Solid Tumors,
80 Guest Street, Suite 601, Boston, MA 02135, US HQ
2014 Founded
54 Employees
Public company Type
CMPX · NYSE Ticker
Company details
- Status
- Public
- HQ
- 80 Guest Street, Suite 601, Boston, MA 02135, US
- Founded
- 2014
- Employees
- 54
- Programs
- 15
- Drugs
- 3
- Patents
- 100
CTX-009
Phase 2 · small molecule · Glioblastoma
CTX-009 is a small-molecule therapeutic candidate developed by Compass Therapeutics for the treatment of glioblastoma, a highly aggressive primary brain malignancy. The program is currently in Phase 2 clinical development with an internal code 202602098. As of the latest disclosed milestone on May 14, 2026, the program
Internal code 202602098
At a glance
- Sponsor
- Compass Therapeutics
- Phase
- Phase 2
- Modality
- small_molecule
- Indication
- Glioblastoma
- Status
- active
- Trials
- 1
Executive summary
CTX-009 is a small-molecule therapeutic candidate developed by Compass Therapeutics for the treatment of glioblastoma, a highly aggressive primary brain malignancy. The program is currently in Phase 2 clinical development with an internal code 202602098. As of the latest disclosed milestone on May 14, 2026, the program remains active, though specific mechanistic details, molecular targets, and clinical efficacy data have not yet been disclosed. Compass Therapeutics is advancing CTX-009 as part of a broader oncology pipeline targeting difficult-to-treat central nervous system malignancies. The competitive landscape for glioblastoma includes multiple Phase 3 candidates and approved therapies, indicating a robust clinical development environment. The program's advancement through Phase 2 represents a critical inflection point in establishing proof-of-concept and dose-response relationships necessary for progression to Phase 3 registration trials.
Why this program matters
Glioblastoma represents one of oncology's most challenging indications, with median overall survival historically ranging from 12–15 months despite multimodal standard-of-care therapy including surgery, radiation, and temozolomide chemotherapy. The disease carries a poor prognosis and limited treatment options, creating substantial unmet medical need. The competitive landscape reveals significant pharmaceutical investment, with multiple Phase 3 programs from established sponsors including AstraZeneca (cediranib), Eli Lilly (enzastaurin), Pfizer (edotecarin), and Novo Nordisk (EF-41/KEYNOTE D58), alongside immunotherapy approaches from Northwest Biotherapeutics and radiopharmaceutical strategies from Lacuna Pharma. CTX-009's positioning as a small-molecule therapeutic in Phase 2 suggests potential differentiation through mechanism or pharmacokinetic properties relevant to blood-brain barrier penetration or tumor microenvironment engagement. Commercial significance is substantial given the high unmet need, orphan disease designation potential, and premium pricing typical of CNS oncology therapeutics. Success in Phase 2 could position CTX-009 for accelerated development pathways if efficacy signals emerge.
Drug intelligence
Drug Class: Small-molecule oncology therapeutic
Modality: Small molecule
Indication: Glioblastoma (WHO Grade IV astrocytoma)
Sponsor: Compass Therapeutics
Mechanism of Action: Not yet disclosed
Molecular Target: Not yet disclosed
Route of Administration: Not yet disclosed
Development Stage: Phase 2 clinical trial
Related Therapies: Temozolomide (alkylating agent, standard-of-care), cediranib (VEGF inhibitor, Phase 3), enzastaurin (PKC inhibitor, Phase 3), edotecarin (topoisomerase I inhibitor, Phase 3)
Patent Status: Not yet disclosed
First Approval: Not applicable; program remains investigational
glioblastoma
Also known as: GBM, GBM (glioblastoma), WHO grade IV glioma, glioblastoma (disease), glioblastoma multiforme, glioblastoma multiforme (disease)
Prevalence: Point prevalence: 1-9 / 100 000 (Worldwide) — source: Orphanet, validated.
Overview
The most malignant astrocytic tumor (WHO grade IV). It is composed of poorly differentiated neoplastic astrocytes and it is characterized by the presence of cellular polymorphism, nuclear atypia, brisk mitotic activity, vascular thrombosis, microvascular proliferation and necrosis. It typically affects adults and is preferentially located in the cerebral hemispheres. It may develop from diffuse astrocytoma WHO grade II or anaplastic astrocytoma (secondary glioblastoma, IDH-mutant), but more frequently, it manifests after a short clinical history de novo, without evidence of a less malignant precursor lesion (primary glioblastoma, IDH- wildtype). (Adapted from WHO)
Treatment landscape
ClinicalTrials.gov lists 877 registered studies for Glioblastoma (AACT aggregate).
Phase breakdown: NA (252), PHASE2 (223), PHASE1 (206), PHASE1/PHASE2 (86), EARLY_PHASE1 (49), PHASE3 (45), PHASE2/PHASE3 (11), PHASE4 (5)
Common investigational therapies:
- Temozolomide
- Bevacizumab
- Lomustine
- Pembrolizumab
- Nivolumab
- Placebo
- temozolomide
- Temozolomide (TMZ)
- Cyclophosphamide
- Ipilimumab
Disease data sourced from MONDO Disease Ontology (MONDO:0018177), Orphanet — glioblastoma, NCT00001148, NCT00001171, NCT00009035, NCT00028158, NCT00029783, AACT (ClinicalTrials.gov aggregate), ClinicalTrials.gov, Open Targets Platform (CC BY 4.0).
Clinical development timeline
- Phase 2TBD
Phase 2 enrollment and ongoing assessment
CTX-009 is actively enrolling and evaluating safety, tolerability, and preliminary efficacy in glioblastoma patients.
- Phase 22026-05-14
Latest program milestone
Most recent disclosed activity date; specific milestone details not yet disclosed.
Competitive landscape
The glioblastoma therapeutic landscape includes multiple competing modalities and mechanisms at advanced stages of development. Approved therapies include stereotactic radiation therapy and GTM-103 (GT Biopharma), representing standard and emerging approaches. Phase 3 programs span diverse mechanisms: cediranib (AstraZeneca, VEGF inhibitor), enzastaurin (Eli Lilly, PKC inhibitor), edotecarin (Pfizer, topoisomerase I inhibitor), EF-41/KEYNOTE D58 (Novo Nordisk), temozolomide-based approaches (Adaptive Biotechnologies), and radiopharmaceutical strategies (131I-TLX-101-003 and MIN-003-1806 from Lacuna Pharma). Immunotherapy approaches include dendritic cell immunotherapy (Northwest Biotherapeutics, Phase 3). CTX-009's specific mechanism remains undisclosed, limiting direct competitive positioning; however, as a Phase 2 small-molecule candidate, it likely targets a distinct pathway or addresses a specific resistance mechanism. The density of Phase 3 programs suggests competitive pressure and potential for differentiation through superior efficacy, tolerability, or pharmacokinetic properties relevant to CNS penetration.
| Therapy | Company | Mechanism | Status |
|---|---|---|---|
| IRON OXIDE (E172) | Disc Medicine | small_molecule | approved |
| Stereotactic Radiation Therapy | GT Biopharma | other | approved |
| GTM-103 | GT Biopharma | other | approved |
| Dendritic cell immunotherapy | NORTHWEST BIOTHERAPEUTICS INC | small_molecule | phase_3 |
| 131I-TLX-101-003 | Lacuna Pharma Pty Ltd | small_molecule | phase_3 |
| Temozolomide | Adaptive Biotechnologies Corp | small_molecule | phase_3 |
| enzastaurin | Eli Lilly and Company | small_molecule | phase_3 |
| EF-41/KEYNOTE D58 | Novo Nordisk A/S | small_molecule | phase_3 |
| MIN-003-1806 | Lacuna Pharma Pty Ltd | small_molecule | phase_3 |
| Cediranib | AstraZeneca | small_molecule | phase_3 |
| Edotecarin | Pfizer | small_molecule | phase_3 |
| LOMUSTINE | Ningbo Cancer Hospital | small_molecule | phase_3 |
| CARMUSTINE | — | Glutathione reductase inhibitor | Approved |
| BEVACIZUMAB | — | Vascular endothelial growth factor A inhibitor | Approved |
| TRABEDERSEN | — | Transforming growth factor beta-2 mRNA antisense inhibitor | Phase 3 |
| TOFACITINIB | — | Janus Kinase (JAK) inhibitor | Phase 3 |
| RINDOPEPIMUT | — | Epidermal growth factor receptor erbB1 vaccine antigen | Phase 3 |
| OMBIPEPIMUT-S | — | Wilms tumor protein vaccine antigen | Phase 3 |
| NIVOLUMAB | — | Programmed cell death protein 1 inhibitor | Phase 3 |
| NIMOTUZUMAB | — | Epidermal growth factor receptor erbB1 inhibitor | Phase 3 |
Additional associated therapies sourced from Open Targets Platform (CC0), linked to NovaPharmaNews drug profiles where matched.
Regulatory intelligence
FDA Status: Not yet disclosed. CTX-009 is an investigational new drug in Phase 2 development; regulatory designation (orphan drug, breakthrough therapy, fast track) status is not yet disclosed.
EMA Status: Not yet disclosed.
PMDA (Japan) Status: Not yet disclosed.
NMPA (China) Status: Not yet disclosed.
As a Phase 2 program, CTX-009 has not yet submitted regulatory applications for marketing approval in any jurisdiction. Progression to Phase 3 and subsequent regulatory filings will depend on Phase 2 efficacy and safety data. Regulatory strategy, including potential expedited pathways, will likely be informed by competitive positioning and unmet medical need in glioblastoma.
Clinical evidence summary
Key questions answered
What is CTX-009 used for?
CTX-009 is an investigational small-molecule therapeutic being developed by Compass Therapeutics for the treatment of glioblastoma, a highly aggressive primary brain cancer.
Is CTX-009 approved by the FDA?
No. CTX-009 is currently in Phase 2 clinical development and has not yet been submitted for FDA approval or received marketing authorization.
What is the mechanism of action of CTX-009?
The specific mechanism of action of CTX-009 has not yet been disclosed by Compass Therapeutics.
Who manufactures CTX-009?
CTX-009 is developed and sponsored by Compass Therapeutics. Manufacturing and commercial partner details have not been disclosed.
What is the current development phase of CTX-009?
CTX-009 is currently in Phase 2 clinical development as of May 2026, with active enrollment and ongoing safety and efficacy assessment.
What clinical trial is evaluating CTX-009?
CTX-009 is being evaluated in clinical trial NCT07392957; specific trial design, endpoints, and enrollment details have not yet been disclosed.
What is the molecular target of CTX-009?
The molecular target of CTX-009 has not yet been disclosed by Compass Therapeutics.
What is the route of administration for CTX-009?
The route of administration (oral, intravenous, intrathecal, etc.) for CTX-009 has not yet been disclosed.
Does CTX-009 have orphan drug designation?
Orphan drug designation status for CTX-009 has not been disclosed.
What are the main competitors to CTX-009?
Competing glioblastoma therapies in development include cediranib (AstraZeneca, Phase 3), enzastaurin (Eli Lilly, Phase 3), edotecarin (Pfizer, Phase 3), and dendritic cell immunotherapy (Northwest Biotherapeutics, Phase 3), among others.
When is CTX-009 expected to complete Phase 2?
The expected Phase 2 completion date and data readout timeline have not been disclosed.
Does Compass Therapeutics have a partner for CTX-009?
No partnership or licensing arrangement for CTX-009 has been disclosed as of the latest available information.
What is the unmet medical need in glioblastoma?
Glioblastoma has poor prognosis with median overall survival of 12–15 months despite standard multimodal therapy, creating significant unmet need for more effective treatments.
What is the patient population for CTX-009?
CTX-009 is being developed for patients with glioblastoma; specific patient selection criteria (newly diagnosed vs. recurrent, biomarker-defined subsets) have not been disclosed.
What is the commercial significance of CTX-009?
Glioblastoma represents a high-value oncology indication with limited treatment options, orphan disease potential, and premium pricing typical of CNS oncology, making successful development commercially significant.
Has CTX-009 received breakthrough therapy designation?
Breakthrough therapy or other expedited regulatory designation status for CTX-009 has not been disclosed.
Entity relationship graph
CTX-009 → Drug → Target → Indication → Company → Trials → Competitors
Companies
Indication
Trials
Analyst insights
Strategic Implications: Compass Therapeutics' advancement of CTX-009 into Phase 2 reflects confidence in the candidate's preclinical profile and potential differentiation in a competitive glioblastoma market. The undisclosed mechanism suggests either proprietary intellectual property protection or ongoing optimization of the development narrative.
Competitive Implications: The Phase 2 status positions CTX-009 approximately 1–2 years behind leading Phase 3 programs (cediranib, enzastaurin, edotecarin). Successful Phase 2 data could enable accelerated Phase 3 enrollment if efficacy signals are compelling. The crowded competitive landscape increases pressure for meaningful differentiation in efficacy, safety, or convenience.
Future Catalysts: Phase 2 interim or final efficacy data release; regulatory designation announcements (orphan drug, breakthrough therapy); Phase 3 initiation announcement; partnership or licensing announcements; biomarker or patient selection strategy disclosures.
Expected Milestones: Phase 2 data readout (timing not yet disclosed); Phase 3 initiation decision; regulatory feedback meetings; potential combination therapy exploration given competitive precedent with checkpoint inhibitors and other modalities.
Quick answers
Concise, citable answers optimized for AI answer engines.
- What is CTX-009?
- Investigational small-molecule therapeutic for glioblastoma by Compass Therapeutics.
- What company develops CTX-009?
- Compass Therapeutics
- What indication is CTX-009 for?
- Glioblastoma (WHO Grade IV brain cancer)
- What is the current phase of CTX-009?
- Phase 2
- Is CTX-009 approved?
- No, CTX-009 is investigational and not yet approved.
- What is the mechanism of action of CTX-009?
- Not yet disclosed
- What is the modality of CTX-009?
- Small molecule
- What is the molecular target of CTX-009?
- Not yet disclosed
- What is the route of administration?
- Not yet disclosed
- Does CTX-009 have a partner?
- No partner disclosed
- What is the internal code for CTX-009?
- 202602098
- What clinical trial evaluates CTX-009?
- NCT07392957
- When was CTX-009 last updated?
- May 14, 2026
- What are key competitors to CTX-009?
- Cediranib, enzastaurin, edotecarin, dendritic cell immunotherapy in Phase 3
- What is the unmet need in glioblastoma?
- Poor prognosis with 12–15 month median survival despite standard therapy
- Is CTX-009 orphan designated?
- Status not disclosed
- What is the commercial potential of CTX-009?
- High; glioblastoma is premium-priced orphan oncology indication
- When will Phase 2 data be available?
- Timeline not yet disclosed
- Does CTX-009 have breakthrough designation?
- Status not disclosed
- What is the regulatory status of CTX-009?
- Investigational; no FDA submission or approval
- Is CTX-009 in combination trials?
- Combination strategy not yet disclosed
- What is the peak sales projection for CTX-009?
- Not yet disclosed
Evidence & sources
- ClinicalTrials.gov NCT07392957 (clinicaltrials)
- Source: phase (source_attribution)
- MONDO Disease Ontology (MONDO:0018177) (mondo)
- Orphanet — glioblastoma (orphanet)
- NCT00001148 (clinicaltrials_gov)
- NCT00001171 (clinicaltrials_gov)
- NCT00009035 (clinicaltrials_gov)
- NCT00028158 (clinicaltrials_gov)
- NCT00029783 (clinicaltrials_gov)
- AACT (ClinicalTrials.gov aggregate) (aact)
- ClinicalTrials.gov (clinicaltrials_gov)
- Open Targets Platform (opentargets)
Intelligence compiled from public regulatory and clinical sources (FDA, EMA, ClinicalTrials.gov and company disclosures). Figures may be editorial or analyst estimates; verify against primary sources before relying on them.