Clinical trial · Interventional
A Study, Combination, Immunologic Study of LTX-315 as Adjunct to GV1001 in Patients Following Curative Surgery for Carcinoma
A Phase I, Combination, Immunologic Study of LTX-315 as Adjunct to GV1001 in Patients Following Curative Surgery for Carcinoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study involves testing of the medicine LTX-315 combined with a cancer vaccine (GV1001). This will be tested in patients that have had surgery with curative intent for malignant tumour. GV1001 is a peptide vaccine in development to treat cancer. An adjuvant, is required to start the immune response in the body to have effect of GV-1001. LTX-315, also a peptide, in development for cancer treatment. In this study, the investigators wish to find out whether LTX-315 can make GV1001 more effective at stimulating the immune system.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Carcinoma | Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| LTX-315 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- LTX-315
- description
- The dose range of 0,25-2.0 mg/ML LTX-315 will be used. In combination with a fixed dose of GV-1001.
- interventionNames
- Drug: LTX-315
Primary outcomes (1)
- measure
- Immunological effects of LTX-315 in combination with GV1001 as measured by DTH skin test reaction and T-cell function in peripheral blood.
- timeFrame
- 5 injections, treatment period 36 days
- description
- Patients will return to the site 24 to 48 hours after the LTX-315 and GV1001 injections for DTH assessment and in week 10 for an end of study assessment.
Secondary outcomes (1)
- measure
- To evaluate the safety profile of LTX-315 in combination with GV1001 study
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Curative surgery for carcinoma performed at least three months prior to treatment start * Age ≥18 years * ECOG Performance status (PS): 0 * Life expectancy: at least 3 months * Laboratory requirements: * White Blood Count (WBC) ≥ 3 x 109/L * Absolute neutrophil count (ANC) ≥ 1.5 x 109/L * Platelet count ≥ 100 x 109/L * Haemoglobin ≥ 10.0 g/dL * Total bilirubin level ≤ 1.5 ULN * AST and ALT ≤ 2.5 x ULN * Creatinine ≥ 1.5 ULN * Albumin \> 30 g/L * No expectation of anti-cancer therapy or immunotherapy during the trial period, hormone therapy given as adjunctive or contraceptive therapy is permitted * Must be willing to practice acceptable barrier methods of birth control to prevent pregnancy * The patient is willing and able to comply with the protocol and agrees to return to the hospital for follow-up visits and examination * The patient has been fully informed about the study and has signed the informed consent form Exclusion Criteria: * Has received an investigational drug within 4 weeks prior to study drug administration, or is scheduled to receive one during the treatment or the post-treatment period * Has received immunotherapy or been vaccinated within 12 weeks prior to study drug administration or has not recovered from adverse events due to such agents * Has received external radiotherapy or cytotoxic chemotherapy within the last 4 weeks prior to study drug administration, or has not recovered from adverse events (\< Grade 1) due to agents administered more than 4 weeks earlier * Has received imiquimod within 12 weeks prior to study drug administration or has not recovered from associated adverse events * Is currently on any agent with a known effect on the immune system * Has any other serious illness or medical condition such as but not limited to: * Any uncontrolled infection or infection requiring antibiotics * Uncontrolled cardiac failure Classification III or IV (New York Heart Association) * Uncontrolled systemic and gastro-intestinal inflammatory conditions * Bone marrow dysplasia * History of auto-immune disease * History of adverse reaction to vaccines * Known history of positive tests for HIV/AIDS, hepatitis B or C * Is pregnant or breastfeeding
References
Publications (0)
Data not yet available