Non-small Cell Lung CancerPhase 1NCT05374538
VIC-1911 Monotherapy in Combination With Sotorasib for the Treatment of KRAS G12C-Mutant Non-Small Cell Lung Cancer
A Phase 1 study testing VIC-1911 and sotorasib in people with Non-small Cell Lung Cancer, run by Vitrac Therapeutics, LLC at 5 sites in United States.
Trial summary
This is a Phase 1a/1b study of aurora kinase A inhibitor VIC-1911 administered as monotherapy and in combination with sotorasib for the treatment of locally advanced or metastatic KRAS G12C-mutant non-small cell lung cancer(NSCLC). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer
- What is being tested?
- VIC-1911 and sotorasib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 5 sitesUnited States
- Study dates
- 9 Nov 2022to 26 Aug 2023
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Males and females ≥ 18 years of age
- Have locally advanced or metastatic histologically or cytologically confirmed NSCLC, KRAS G12C-mutated
- The presence of a KRAS G12C mutation should be established prior to entry as assessed in a CLIA qualified laboratory. Testing may be done on tumor tissue (archival or fresh) or on ctDNA from blood.
- Have received at least 1 prior line of cancer therapy with a PD-1 or PD-L1 inhibitor with or without platinum-based chemotherapy (unless subject is not eligible or refuses chemotherapy or PD-1/PD-L1 therapy and have documented progression on all prior cancer therapies
- Dose Escalation Phase:
- Cohort 1a: (VIC-1911 monotherapy): Locally advanced or metastatic NSCLC refractory to or relapsed on at least 1 prior cancer therapy as noted above, and relapsed/refractory on KRAS G12C inhibitor therapy as the most recent cancer therapy prior to study
Show all 30Show fewer
- Cohort 1b: (VIC-1911 plus sotorasib): Locally advanced or metastatic NSCLC:
- Refractory to or relapsed on at least 1 prior cancer therapy as noted above, and relapsed/refractory on KRAS G12C inhibitor therapy as the most recent cancer therapy prior to study, or
- Refractory to or relapsed on at least 1 prior cancer therapy as noted above, and Naïve to KRAS G12C inhibitor therapy
- Expansion Phase 1b:
- Cohort 2a: (VIC-1911 monotherapy): Locally advanced or metastatic NSCLC refractory to or relapsed on at least 1 prior cancer therapy as noted above, and relapsed/refractory on KRAS G12C inhibitor therapy as the most recent cancer therapy prior to study
- Cohort 2b: (VIC-1911 plus sotorasib): Locally advanced or metastatic NSCLC refractory to or relapsed on at least 1 prior cancer therapy as noted above, and relapsed/refractory on KRAS G12C inhibitor therapy as the most recent cancer therapy prior to study
- Cohort 2c: (VIC-1911 plus sotorasib): Locally advanced or metastatic NSCLC refractory to or relapsed on at least 1 prior cancer therapy as noted above, and naïve to KRAS G12C inhibitor therapy
- Measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
- Have discontinued previous treatments for cancer, except for sotorasib for subjects to receive VIC-1911 plus sotorasib combination treatment, and have resolution, except where otherwise stated in the inclusion criteria, of all clinically significant toxic effects of prior cancer treatment, surgery, or radiotherapy to Grade ≤ 1
- Adequate performance status: Eastern Cooperative Oncology Group (ECOG) ≤ 2
- Life expectancy of ≥ 3 months
- Subjects with brain metastases:
- 11.1 KRAS G12C inhibitor naïve: Subjects with clinically stable (i.e., no increase in corticosteroid requirement) asymptomatic brain metastases are allowed without prior local therapy, as long as all lesions are each ≤ 1 cm. Prior local therapy is required (e.g., stereotactic radiosurgery [SRS], stereotactic body radiation therapy [SBRT], or surgery) for any lesion > 1 cm or any lesion that is symptomatic. Subjects must be clinically stable and asymptomatic following local therapy.
- 11.2 KRAS G12C inhibitor pretreated: Subjects with clinically stable (i.e., no increase in corticosteroid requirement) asymptomatic brain metastases following prior local therapy (e.g., SRS, SBRT or surgery) are allowed.
- Adequate hematologic without ongoing transfusion support:
- Hemoglobin (Hb) ≥ 8 g/dL
- Absolute neutrophil count (ANC) ≥ 1.0 x 10^9 cells/L
- Platelets ≥ 75 x 10^9 cells/L
- Adequate renal and hepatic function:
- Calculated creatinine clearance ≥ 50 mL/minute x 1.73 m2 per the Cockcroft-Gault formula
- Total bilirubin ≤ 1.5 times the ULN, unless due to Gilbert's disease, or < 3 times the ULN for subjects with liver metastases
- ALT/AST ≤ 2 times the ULN, or < 3 times the ULN for subjects with liver metastases
- Negative serum pregnancy test within 14 days prior to the first dose of study therapy for women of child-bearing potential (WCBP). Sexually active WCBP and male subjects must agree to use adequate methods to avoid pregnancy throughout the study and for 28 days after the completion of study treatment.
- Ability to proved written informed consent
Who cannot join
- Serious cardiac condition within the last 6 months, such as uncontrolled arrhythmia, myocardial infarction, unstable angina or heart disease defined by the New York Heart Association (NYHA) Class III or Class IV
- QT interval corrected for rate (QTc) > 480 msec on the ECG obtained at Screening using Fridericia method for QTc calculation
- Medications that are inhibitors or inducers of UDP-glucuronosyltransferases (UGTs) are prohibited in the Dose Escalation Phase
- History of corneal epithelial cysts or other ocular events leading to blurred vision, or has medically relevant abnormalities identified on screening ophthalmologic examination
- Symptomatic pneumonitis/interstitial lung disease requiring medical intervention
- Symptomatic central nervous system metastasis
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- Leptomeningeal carcinomatosis
- Inability to swallow oral medication
- Gastrointestinal conditions that could impair absorption or tolerance of study drugs
- Current hematologic malignancies
- Second, active primary solid tumor malignancy that, in the judgement of the Investigator or Sponsor Medical Monitor, may affect the interpretation of results, with the exception of carcinoma in situ of any origin, non-muscle invasive bladder cancer, and Gleason < 3+3 prostate cancer
- Active infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV) requiring treatment within the last week prior to study treatment
- Other active infection requiring IV antibiotic usage within the last week prior to study treatment
- Unable to tolerate marketed dose of KRAS G12C inhibitor on prior therapy for subjects to be enrolled in combination VIC-1911 plus sotorasib treatment cohorts. Alternatively, these subjects may be able to enroll in the VIC-1911 monotherapy treatment cohort, upon discussion with the Medical Monitor and Study Chair.
- Previous MEK or EGFR inhibitor therapy
- Any other medical intervention or other condition which, in the opinion of the Principal Investigator, could compromise adherence to study requirements or confound the interpretation of study results
- Receipt of an investigational product on a clinical trial within 5 elimination half-lives or within 28 days, whichever is shorter, prior to C1D1 on this study, or currently enrolled in a clinical trial involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study
- Previously completed or withdrawn from any other study investigating an aurora kinase A inhibitor
- Known hypersensitivity to VIC-1911 or its components
- If female, pregnant, breast-feeding, or planning to become pregnant
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Emory University Winship Cancer Center
Atlanta, Georgia, 30322
University of Maryland Cancer Center
Baltimore, Maryland, 21201
New York University Langone Health Perlmutter Cancer Cancer
New York, New York, 10016
Yale Cancer Center
North Haven, Connecticut, 06473
University of California Davis
Sacramento, California, 95817
About this study
Official title: A Phase 1a/1b Study of Aurora Kinase A Inhibitor VIC-1911 Monotherapy and in Combination With Sotorasib for the Treatment of KRAS G12C-Mutant Non-Small Cell Lung Cancer
This is a Phase 1a/1b study of aurora kinase A inhibitor VIC-1911 administered as monotherapy and in combination with sotorasib for the treatment of locally advanced or metastatic KRAS G12C-mutant non-small cell lung cancer(NSCLC).
Read the detailed description
Selected subjects will include males and females age ≥18 years; histologically confirmed locally advanced or metastatic KRAS G12C-mutated NSCLC; received at least 1 prior line of cancer therapy with a PD-1 or PD-L1 inhibitor with or without platinum-based chemotherapy; recovered from all acute toxicities (≤ Grade 1) due to prior therapy; adequate renal and hepatic function; and no known history of significant cardiac, hepatic or ocular disease.
Dose Escalation Phase:
Following screening, a total of up to 36 subjects are anticipated to establish the dose limiting toxicity (DLT) and maximum tolerated doses (MTDs) of VIC-1911 monotherapy and VIC-1911 in combination with sotorasib therapy.
Cohort 1a: Subjects who are refractory to or relapsed on prior KRAS G12C inhibitor therapy will receive VIC-1911 monotherapy. Up to 24 subjects are anticipated in this cohort.
Cohort 1b: Subjects who are refractory to or relapsed on prior KRAS G12C inhibitor therapy or are naïve to KRASG12C inhibitor therapy will receive VIC-1911 plus sotorasib combination therapy. Up to 12 subjects are anticipated in this cohort.
A 3+3 dose escalation schema will be followed to establish the dose limiting toxicity (DLT) and maximum tolerated dose (MTD) of VIC-1911 and VIC-1911 plus sotorasib combination. A total of at least 6 subjects will be treated at the MTD in each group before initiating the Expansion Phase.
Expansion Phase:
Following screening, a total of 104 subjects with KRAS G12C-mutated locally advanced or metastatic NSCLC are anticipated to expand the disease treatment settings of VIC-1911 as monotherapy or in combination with sotorasib. VIC-1911 monotherapy and VIC-1911 plus sotorasib combination therapy will be administered orally at the MTDs established during the Dose Escalation Phase.
Cohort 2a: Subjects who are refractory to or relapsed on prior KRAS G12C inhibitor therapy will receive VIC-1911 monotherapy. (n=29)
Cohort 2b: Subjects who are refractory to or relapsed on prior KRAS G12C inhibitor therapy will receive VIC-1911 plus sotorasib combination therapy.(n=29)
Cohort 2c: Subjects who are naïve to KRAS G12C inhibitor therapy will receive VIC-1911 plus sotorasib combination therapy. (n=46)
VIC-1911 and sotorasib will be taken in the fasted state, 1 hour before or 2 hours after a meal.
Subjects who demonstrate clinical benefit (CR, PR or SD) will be allowed to continue therapy with VIC-1911 and sotorasib until progression of disease, observation of unacceptable adverse events, intercurrent illness or changes in the subject's condition that prevents further study participation.
Disease response will be assessed according to Response Evaluation Criteria in Solid Tumors (RECIST v.1.1).
Blood for hematology, coagulation parameters and serum chemistry determinations and urine will be collected, ECGs will be taken and ophthalmologic exams will be conducted during the study.
Blood will be taken for PK assessment of VIC-1911 and PD assessment of circulating tumor DNA biomarker determinations.
Tumor biopsies will be taken from consenting subjects at Screening and on-study for correlative biomarker determinations. Results will be correlated with clinical outcome.
- Conditions
- Non-small Cell Lung Cancer
- Being tested
- VIC-1911, sotorasib
- Keywords
- KRAS G12C mutation, AURA kinase, VIC-1911, KRAS G12C, sotorasib
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VIC-1911Drug
VIC-1911 tablets for oral administration
sotorasibDrug
Also called LUMAKRAS
Sotorasib tablets for oral administration
| Study group | Role | What they receive |
|---|---|---|
| Dose Escalation Phase, Cohort 1a: VIC-1911 monotherapy | Experimental | Subjects with locally advanced or metastatic KRAS G12C-mutated NSCLC refractory to or relapsed on prior KRASG12C inhibitor therapy will receive VIC-1911 monotherapy. Receives: Drug: VIC-1911 |
| Dose Escalation Phase, Cohort 1b: VIC-1911 plus sotorasib combination therapy | Experimental | Subjects with locally advanced or metastatic KRAS G12C-mutated NSCLC refractory to or relapsed on prior KRASG12C inhibitor therapy or are naive to KRAS G12C inhibitor therapy will receive VIC-1911 plus sotorasib combination therapy.
Only Dose Level 1 was opened and all 3 subjects received sotorasib 960 mg QD PO, VIC-1911 75 mg BID PO. Receives: Drug: VIC-1911; Drug: sotorasib |
| Expansion Phase, Cohort 2a: VIC-1911 monotherapy | Experimental | Subjects with locally advanced or metastatic KRAS G12C-mutated NSCLC refractory to or relapsed on prior KRASG12C inhibitor therapy will receive VIC-1911 monotherapy. Receives: Drug: VIC-1911 |
| Expansion Phase, Cohort 2b: VIC-1911 plus sotorasib combination therapy | Experimental | Subjects with locally advanced or metastatic KRAS G12C-mutated NSCLC refractory to or relapsed on prior KRASG12C inhibitor therapy will receive VIC-1911 plus sotorasib combination therapy. Receives: Drug: VIC-1911; Drug: sotorasib |
| Expansion Phase, Cohort 2c: VIC-1911 plus sotorasib combination therapy | Experimental | Subjects with locally advanced or metastatic KRAS G12C-mutated NSCLC naive to KRAS G12C inhibitor therapy will receive VIC-1911 plus sotorasib combination therapy. Receives: Drug: VIC-1911; Drug: sotorasib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment Emergent Adverse Events (Safety and Tolerability)
Safety and tolerability assessed by adverse events(AEs) and serious adverse events (SAEs)
Measured: 9 months
Secondary outcomes (6)
Objective Response Rate
Proportion of subjects with objective responses (complete response [CR] + partial response [PR]) as assessed by Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1.
Measured: Assessed at the end of Cycle 2 and every 2 cycles thereafter up to 8 months. Each cycle is 28 days.
Duration of Response
Length of time from first evidence of objective response (complete response [CR] or partial response [PR]) to the first objective evidence of disease progression
Measured: Assessed at the end of Cycle 2 and every 2 cycles thereafter up to 8 months. Each cycle is 28 days.
Time to Response
Length of time from the date of first dose of study drug to the first evidence of objective response (CR,PR)
Measured: Assessed at the end of Cycle 2 and every 2 cycles thereafter up to 8 months. Each cycle is 28 days.
Disease Control Rate
Proportion of subjects with best response of CR, PR or stable disease (SD)
Measured: Assessed at the end of Cycle 2 and every 2 cycles thereafter up to 8 months. Each cycle is 28 days.
Progression-Free Survival
Length of time from the date of first dose of study drug to the first evidence of disease progression or death, whichever is earlier
Measured: Assessed from the date of the first dose of study drug to the first evidence of disease progression or death, whichever is earlier, assessed up to 9 months
Overall Survival
Length of time from the date of first dose of study drug to date of death from any cause
Measured: Assessed from the date of the first dose of study drug to date of death from any cause, assessed up to 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2022
- Study start9 Nov 2022
- Primary completion26 Aug 2023
- Study completion26 Aug 2023
Why it stopped: Sponsor decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Non-small Cell Lung CancerStudies 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
- Non-randomised
- Intervention model
- Single group
- Model description
- Dose Escalation Phase followed by Expansion Phase. A total of 24 subjects are anticipated in Dose Escalation Phase, Cohort 1a. A total of 12 subjects are anticipated in Dose Escalation Phase, Cohort 1b. A total of 29 subjects are anticipated in Expansion Phase, Cohort 2a. A total of 29 subjects are anticipated in Expansion Phase, Cohort 2b. A total of 46 subjects are anticipated in Expansion Phase, Cohort 2c.
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vitrac Therapeutics, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Westat
- Responsible party
- Sponsor
- Investigators
- Sarah Goldberg, MD, MPH, Study chair, Yale Cancer Center, Yale UniversityLinda J Paradiso, DVM, Study director, Vitrac Therapeutics, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05374538
- Sponsor's protocol ID
- VIC-1911-01
- Status last verified
- Mar 2025
- First submitted
- 10 May 2022
- Last updated
- 1 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1a/1b Study of Aurora Kinase A Inhibitor VIC-1911 Monotherapy and in Combination With Sotorasib for the Treatment of KRAS G12C-Mutant Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT05374538
- Acronym / sponsor ID
- VIC-1911-01
- Conditions
- Non-small Cell Lung Cancer
- Keywords
- KRAS G12C mutation, AURA kinase, VIC-1911, KRAS G12C, sotorasib
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor decision
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Vitrac Therapeutics, LLCIndustry (pharma, biotech, devices)
- Collaborators
- Westat
- Study start
- 9 Nov 2022 (actual)
- Primary completion
- 26 Aug 2023 (actual)
- Study completion
- 26 Aug 2023 (actual)
- First posted
- 16 May 2022 (actual)
- Results
- Posted 1 May 2025
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 Phase 1a/1b study of aurora kinase A inhibitor VIC-1911 administered as monotherapy and in combination with sotorasib for the treatment of locally advanced or metastatic KRAS G12C-mutant non-small cell lung cancer(NSCLC).
Detailed description
Selected subjects will include males and females age ≥18 years; histologically confirmed locally advanced or metastatic KRAS G12C-mutated NSCLC; received at least 1 prior line of cancer therapy with a PD-1 or PD-L1 inhibitor with or without platinum-based chemotherapy; recovered from all acute toxicities (≤ Grade 1) due to prior therapy; adequate renal and hepatic function; and no known history of significant cardiac, hepatic or ocular disease.
Dose Escalation Phase:
Following screening, a total of up to 36 subjects are anticipated to establish the dose limiting toxicity (DLT) and maximum tolerated doses (MTDs) of VIC-1911 monotherapy and VIC-1911 in combination with sotorasib therapy.
Cohort 1a: Subjects who are refractory to or relapsed on prior KRAS G12C inhibitor therapy will receive VIC-1911 monotherapy. Up to 24 subjects are anticipated in this cohort.
Cohort 1b: Subjects who are refractory to or relapsed on prior KRAS G12C inhibitor therapy or are naïve to KRASG12C inhibitor therapy will receive VIC-1911 plus sotorasib combination therapy. Up to 12 subjects are anticipated in this cohort.
A 3+3 dose escalation schema will be followed to establish the dose limiting toxicity (DLT) and maximum tolerated dose (MTD) of VIC-1911 and VIC-1911 plus sotorasib combination. A total of at least 6 subjects will be treated at the MTD in each group before initiating the Expansion Phase.
Expansion Phase:
Following screening, a total of 104 subjects with KRAS G12C-mutated locally advanced or metastatic NSCLC are anticipated to expand the disease treatment settings of VIC-1911 as monotherapy or in combination with sotorasib. VIC-1911 monotherapy and VIC-1911 plus sotorasib combination therapy will be administered orally at the MTDs established during the Dose Escalation Phase.
Cohort 2a: Subjects who are refractory to or relapsed on prior KRAS G12C inhibitor therapy will receive VIC-1911 monotherapy. (n=29)
Cohort 2b: Subjects who are refractory to or relapsed on prior KRAS G12C inhibitor therapy will receive VIC-1911 plus sotorasib combination therapy.(n=29)
Cohort 2c: Subjects who are naïve to KRAS G12C inhibitor therapy will receive VIC-1911 plus sotorasib combination therapy. (n=46)
VIC-1911 and sotorasib will be taken in the fasted state, 1 hour before or 2 hours after a meal.
Subjects who demonstrate clinical benefit (CR, PR or SD) will be allowed to continue therapy with VIC-1911 and sotorasib until progression of disease, observation of unacceptable adverse events, intercurrent illness or changes in the subject's condition that prevents further study participation.
Disease response will be assessed according to Response Evaluation Criteria in Solid Tumors (RECIST v.1.1).
Blood for hematology, coagulation parameters and serum chemistry determinations and urine will be collected, ECGs will be taken and ophthalmologic exams will be conducted during the study.
Blood will be taken for PK assessment of VIC-1911 and PD assessment of circulating tumor DNA biomarker determinations.
Tumor biopsies will be taken from consenting subjects at Screening and on-study for correlative biomarker determinations. Results will be correlated with clinical outcome.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 5
- Model description
- Dose Escalation Phase followed by Expansion Phase. A total of 24 subjects are anticipated in Dose Escalation Phase, Cohort 1a. A total of 12 subjects are anticipated in Dose Escalation Phase, Cohort 1b. A total of 29 subjects are anticipated in Expansion Phase, Cohort 2a. A total of 29 subjects are anticipated in Expansion Phase, Cohort 2b. A total of 46 subjects are anticipated in Expansion Phase, Cohort 2c.
| Arm | Type | Receives |
|---|---|---|
| Dose Escalation Phase, Cohort 1a: VIC-1911 monotherapy | Experimental | Drug: VIC-1911Subjects with locally advanced or metastatic KRAS G12C-mutated NSCLC refractory to or relapsed on prior KRASG12C inhibitor therapy will receive VIC-1911 monotherapy. |
| Dose Escalation Phase, Cohort 1b: VIC-1911 plus sotorasib combination therapy | Experimental | Drug: VIC-1911, Drug: sotorasibSubjects with locally advanced or metastatic KRAS G12C-mutated NSCLC refractory to or relapsed on prior KRASG12C inhibitor therapy or are naive to KRAS G12C inhibitor therapy will receive VIC-1911 plus sotorasib combination therapy. Only Dose Level 1 was opened and all 3 subjects received sotorasib 960 mg QD PO, VIC-1911 75 mg BID PO. |
| Expansion Phase, Cohort 2a: VIC-1911 monotherapy | Experimental | Drug: VIC-1911Subjects with locally advanced or metastatic KRAS G12C-mutated NSCLC refractory to or relapsed on prior KRASG12C inhibitor therapy will receive VIC-1911 monotherapy. |
| Expansion Phase, Cohort 2b: VIC-1911 plus sotorasib combination therapy | Experimental | Drug: VIC-1911, Drug: sotorasibSubjects with locally advanced or metastatic KRAS G12C-mutated NSCLC refractory to or relapsed on prior KRASG12C inhibitor therapy will receive VIC-1911 plus sotorasib combination therapy. |
| Expansion Phase, Cohort 2c: VIC-1911 plus sotorasib combination therapy | Experimental | Drug: VIC-1911, Drug: sotorasibSubjects with locally advanced or metastatic KRAS G12C-mutated NSCLC naive to KRAS G12C inhibitor therapy will receive VIC-1911 plus sotorasib combination therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (30 listed)
- Males and females ≥ 18 years of age
- Have locally advanced or metastatic histologically or cytologically confirmed NSCLC, KRAS G12C-mutated
- The presence of a KRAS G12C mutation should be established prior to entry as assessed in a CLIA qualified laboratory. Testing may be done on tumor tissue (archival or fresh) or on ctDNA from blood.
- Have received at least 1 prior line of cancer therapy with a PD-1 or PD-L1 inhibitor with or without platinum-based chemotherapy (unless subject is not eligible or refuses chemotherapy or PD-1/PD-L1 therapy and have documented progression on all prior cancer therapies
- Dose Escalation Phase:
Key exclusion criteria (20 listed)
- Serious cardiac condition within the last 6 months, such as uncontrolled arrhythmia, myocardial infarction, unstable angina or heart disease defined by the New York Heart Association (NYHA) Class III or Class IV
- QT interval corrected for rate (QTc) > 480 msec on the ECG obtained at Screening using Fridericia method for QTc calculation
- Medications that are inhibitors or inducers of UDP-glucuronosyltransferases (UGTs) are prohibited in the Dose Escalation Phase
- History of corneal epithelial cysts or other ocular events leading to blurred vision, or has medically relevant abnormalities identified on screening ophthalmologic examination
- Symptomatic pneumonitis/interstitial lung disease requiring medical intervention
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 |
|---|---|---|
| VIC-1911VIC-1911 tablets for oral administration | Drug | Dose Escalation Phase, Cohort 1a: VIC-1911 monotherapy, Dose Escalation Phase, Cohort 1b: VIC-1911 plus sotorasib combination therapy, Expansion Phase, Cohort 2a: VIC-1911 monotherapy, Expansion Phase, Cohort 2b: VIC-1911 plus sotorasib combination therapy, Expansion Phase, Cohort 2c: VIC-1911 plus sotorasib combination therapy |
| sotorasibAlso: LUMAKRASSotorasib tablets for oral administration | Drug | Dose Escalation Phase, Cohort 1b: VIC-1911 plus sotorasib combination therapy, Expansion Phase, Cohort 2b: VIC-1911 plus sotorasib combination therapy, Expansion Phase, Cohort 2c: VIC-1911 plus sotorasib combination therapy |
Primary outcome
Incidence of Treatment Emergent Adverse Events (Safety and Tolerability)
Time frame: 9 months
Safety and tolerability assessed by adverse events(AEs) and serious adverse events (SAEs)
6 secondary outcomes
Objective Response Rate
Time frame: Assessed at the end of Cycle 2 and every 2 cycles thereafter up to 8 months. Each cycle is 28 days.
Duration of Response
Time frame: Assessed at the end of Cycle 2 and every 2 cycles thereafter up to 8 months. Each cycle is 28 days.
Time to Response
Time frame: Assessed at the end of Cycle 2 and every 2 cycles thereafter up to 8 months. Each cycle is 28 days.
Disease Control Rate
Time frame: Assessed at the end of Cycle 2 and every 2 cycles thereafter up to 8 months. Each cycle is 28 days.
Progression-Free Survival
Time frame: Assessed from the date of the first dose of study drug to the first evidence of disease progression or death, whichever is earlier, assessed up to 9 months
Overall Survival
Time frame: Assessed from the date of the first dose of study drug to date of death from any cause, assessed up to 9 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Sarah Goldberg, MD, MPH study chair
Yale Cancer Center, Yale University
Linda J Paradiso, DVM study director
Vitrac Therapeutics, LLC
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing VIC-1911 and sotorasib in people with Non-small Cell Lung Cancer, run by Vitrac Therapeutics, LLC at 5 sites in United States.
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 30 inclusion and 20 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: stopped early, as of the sponsor's last update on 1 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Yes. Results are posted in the registry (first posted 1 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Treatment Emergent Adverse Events (Safety and Tolerability) (time frame: 9 months). 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 1 May 2025.